Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607890745919 Date of Registration: 23/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Surgical repair of Anomalous Coronary Artery from the Pulmonary Artery at the Red Cross War Memorial Hospital, Cape Town: A 13-year review of surgical practice and outcomes
Official scientific title Surgical repair of Anomalous Coronary Artery from the Pulmonary Artery at the Red Cross War Memorial Hospital, Cape Town: A 13-year review of surgical practice and outcomes
Brief summary describing the background and objectives of the trial Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) is a rare congenital heart defect where the left coronary artery incorrectly arises from the pulmonary artery instead of the aorta, affecting 1 in 21,000 to 300,000 live births. ALCAPA is generally assymptomatic at birth, but if untreated, ALCAPA is fatal in 90% of cases, with most children presenting with symptoms in infancy. Urgent surgery to reimplant the coronary artery into the aorta achieves a 94-98% survival rate in high-income countries (HICs). However, in low- and middle-income countries (LMICs) like South Africa, data on ALCAPA repair outcomes remain limited, with most small studies indicating higher mortality and often delays in surgery. We will conduct a retrospective study of children diagnosed with ALCAPA at Red Cross War Memorial Children’s Hospital (RCWMCH) over a 13-year period to address this research gap, focusing on the outcomes for the children undergoing ALCAPA repair over this period. The aim of this study is to gain insight into the early and medium-term outcomes of children presenting to RCWMCH with a diagnosis of ALCAPA. Our objectives are to establish the incidence and nature of perioperative mortality and morbidity following ALCAPA repair at RCWMCH and explore any patient or peri-operative factors which are associated with a poor outcome, such as pre-operative clinical states, pre and post operative echocardiography results, surgical technique and post-operative clinical course. The motivation for this study is to provide essential data to guide the refinement of care strategies for ALCAPA patients presenting to our hospital and the public sector in general in South Africa, with the objective of improving overall care for these children.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 28/02/2025
Actual trial start date 28/02/2025
Anticipated date of last follow up 31/08/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 48
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Retrospective observational trial of outcomes following ALCAPA repair 13 year period of data collection (from 2012 to 2025) Retrospective observational trial, using already collected clinical data, of historical patients who underwent surgical repair of ALCAPA 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Including all consecutive patients <18 years of age presenting to RCWMCH undergoing surgical repair of ALCAPA, from January 2012 to January 2025, Patients with a diagnosis of alternative forms of anomalous coronary artery diseases, such as Anomalous Right Coronary Artery from the Pulmonary Artery (ARCAPA), were excluded. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/02/2025 Human Research Ethics Committee University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Room 46, E-52 Old Main Building Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/02/2026 Human Research Ethics Committee University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Room 46, E-52 Old Main Building Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Describe the early and medium-term outcomes following surgical repair of ALCAPA at Red Cross War Memorial Childrens Hospital RCWMCH Patients reviewed over 13 year period from January 2012 to January 2025. Outcomes measured at last follow up.
Secondary Outcome Exploration of factors associated with a poor outcome, including early and intermediate mortality Early mortality defined as as an inpatient during index admission or within 30 days of operation. Intermediate mortality beyond 30 days.
Secondary Outcome Assessment of the inter-rater reliability of retrospective Cardiogenic Shock Staging using the StOP-CS criteria Initial presentation, 24h pre-op, 6, 12 and 24h postop
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memorial Childrens Hospital Klipfontein Rd, Rondebosch Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Red Cross War Memorial Childrens Hospital Klipfontein Rd Cape Town 7700 South Africa
Samson Kendall 43c Halton Road London N1 2EN United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No sponsor NA NA NA South Africa NA - no sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heidi Meyer heidi.meyer@uct.ac.za 0027799988858 Red Cross War Memorial Childrens Hospital RCWMCH
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Consultant Anaesthetist at RCWMCH
Role Name Email Phone Street address
Public Enquiries Samson Kendall samsonkendall@nhs.net +447761949386 43C Halton Road
City Postal code Country Position/Affiliation
London United Kingdom Previous International Clinical Fellow at Red Cross War Memorial Childrens Hospital
Role Name Email Phone Street address
Scientific Enquiries Andre Brooks andre.brooks@uct.ac.za +27849511162 Department of Cardiothoracic Surgery, Red Cross War Memorial Childrens Hospital
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Professor and Consultant Surgeon in Paediatric Cardiothoracic Surgery at Red Cross Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study will not be made publicly available because of the risk of re-identification of children with Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) and restrictions imposed by institutional and data governance policies. Study Protocol 6 months Researchers with a methodologically sound proposal may request access to aggregated data and supporting study documentation from the corresponding author, subject to appropriate ethical approvals, data-sharing agreements, and institutional review.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 09/07/2026 Request to add aims/objectives from PACTR panel Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) is a rare congenital heart defect where the left coronary artery incorrectly arises from the pulmonary artery instead of the aorta, affecting 1 in 21,000 to 300,000 live births. At birth, symptoms are minimal due to high pulmonary artery pressure, but as pulmonary resistance drops in infancy, reduced blood flow to the heart muscle can cause heart failure. If untreated, ALCAPA is fatal in 90% of cases, with most children presenting symptoms within their first year of life. Urgent surgery to reimplant the coronary artery into the aorta achieves a 94-98% survival rate in high-income countries (HICs). However, in low- and middle-income countries (LMICs) like South Africa, data on ALCAPA repair outcomes remain limited, with most of these small studies indicating higher mortality and delays in surgery. At Red Cross War Memorial Children’s Hospital (RCWMCH), we perform around 200 cardiac surgeries annually. We will conduct a retrospective study on children diagnosed with ALCAPA over a 12-year period to address this research gap. Key South African studies offer preliminary insights include a 38-patient cohort study from Chris Hani hospital which revealed prolonged delays from diagnosis to surgical repair of 28 days. Meanwhile, in a study from Universitas involving 30 patients, 20% of children died without undergoing surgical repair, and for those that did access surgery, over 20% of children died from perioperative complications, emphasising early intervention to reduce risks. In a small audit of ALCAPA patients from RCWMCH, sepsis was found to be a major complication in South Africa, which comparatively is scarcely reported to causes death in the ALPACA patient cohort in HICs. A comprehensive RCWMCH study on ALCAPA outcomes in South African children will provide essential data to refine care strategies and provide targeted interventions at improving outcome for these children. Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) is a rare congenital heart defect where the left coronary artery incorrectly arises from the pulmonary artery instead of the aorta, affecting 1 in 21,000 to 300,000 live births. At birth, symptoms are minimal due to high pulmonary artery pressure, but as pulmonary resistance drops in infancy, reduced blood flow to the heart muscle can cause heart failure. If untreated, ALCAPA is fatal in 90% of cases, with most children presenting symptoms within their first year of life. Urgent surgery to reimplant the coronary artery into the aorta achieves a 94-98% survival rate in high-income countries (HICs). However, in low- and middle-income countries (LMICs) like South Africa, data on ALCAPA repair outcomes remain limited, with most small studies indicating higher mortality and often delays in surgery. At Red Cross War Memorial Children’s Hospital (RCWMCH), we perform around 200 cardiac surgeries annually. We will conduct a retrospective study on children diagnosed with ALCAPA over a 13-year period to address this research gap, looking at the outcomes for the children undergoing ALCAPA repair over this period. Specifically, we will look at early and intermediate term mortality, both early and late complications, and explore any patient or peri-operative factors which are associated with a poor outcome, such as pre-operative clinical states, pre and post operative echocardiography results, surgical technique and post-operative clinical course. A comprehensive RCWMCH study on ALCAPA outcomes in South African children will provide essential data to refine care strategies and provide targeted interventions at improving outcome for these children.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 16/07/2026 Request from PACTR to be more specific on Aims and Objectives Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) is a rare congenital heart defect where the left coronary artery incorrectly arises from the pulmonary artery instead of the aorta, affecting 1 in 21,000 to 300,000 live births. At birth, symptoms are minimal due to high pulmonary artery pressure, but as pulmonary resistance drops in infancy, reduced blood flow to the heart muscle can cause heart failure. If untreated, ALCAPA is fatal in 90% of cases, with most children presenting symptoms within their first year of life. Urgent surgery to reimplant the coronary artery into the aorta achieves a 94-98% survival rate in high-income countries (HICs). However, in low- and middle-income countries (LMICs) like South Africa, data on ALCAPA repair outcomes remain limited, with most small studies indicating higher mortality and often delays in surgery. At Red Cross War Memorial Children’s Hospital (RCWMCH), we perform around 200 cardiac surgeries annually. We will conduct a retrospective study on children diagnosed with ALCAPA over a 13-year period to address this research gap, looking at the outcomes for the children undergoing ALCAPA repair over this period. Specifically, we will look at early and intermediate term mortality, both early and late complications, and explore any patient or peri-operative factors which are associated with a poor outcome, such as pre-operative clinical states, pre and post operative echocardiography results, surgical technique and post-operative clinical course. A comprehensive RCWMCH study on ALCAPA outcomes in South African children will provide essential data to refine care strategies and provide targeted interventions at improving outcome for these children. Anomalous Left Coronary Artery from the Pulmonary Artery (ALCAPA) is a rare congenital heart defect where the left coronary artery incorrectly arises from the pulmonary artery instead of the aorta, affecting 1 in 21,000 to 300,000 live births. ALCAPA is generally assymptomatic at birth, but if untreated, ALCAPA is fatal in 90% of cases, with most children presenting with symptoms in infancy. Urgent surgery to reimplant the coronary artery into the aorta achieves a 94-98% survival rate in high-income countries (HICs). However, in low- and middle-income countries (LMICs) like South Africa, data on ALCAPA repair outcomes remain limited, with most small studies indicating higher mortality and often delays in surgery. We will conduct a retrospective study of children diagnosed with ALCAPA at Red Cross War Memorial Children’s Hospital (RCWMCH) over a 13-year period to address this research gap, focusing on the outcomes for the children undergoing ALCAPA repair over this period. The aim of this study is to gain insight into the early and medium-term outcomes of children presenting to RCWMCH with a diagnosis of ALCAPA. Our objectives are to establish the incidence and nature of perioperative mortality and morbidity following ALCAPA repair at RCWMCH and explore any patient or peri-operative factors which are associated with a poor outcome, such as pre-operative clinical states, pre and post operative echocardiography results, surgical technique and post-operative clinical course. The motivation for this study is to provide essential data to guide the refinement of care strategies for ALCAPA patients presenting to our hospital and the public sector in general in South Africa, with the objective of improving overall care for these children.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 02/07/2026 Error made on initial submission - all children <18 years of age are eligible New born: 0 Day-1 Month, Infant: 1 Month(s)-12 Month(s), Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year(s)-17 Year(s) New born: 0 Day-1 Month, Infant: 13 Month(s)-24 Month(s), Infant: 1 Month(s)-12 Month(s), Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year(s)-17 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/07/2026 Comment from PACTR review noted - the original submission was not an intent of not being forthcoming: it's an retrospective observational trial of historical data, not an interventional trial, hence there is no "intervention". However, I have amended as per your recommendation. Experimental Group, Not applicable, , NA, Retrospective trial of historical patients who underwent surgical repair, no intervention, 48, Experimental Group, Retrospective observational trial of outcomes following ALCAPA repair, , 13 year period of data collection (from 2012 to 2025), Retrospective observational trial, using already collected clinical data, of historical patients who underwent surgical repair of ALCAPA, 48,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/07/2026 It was requested that I change the source to "self-funded" on feedback from PACTR NA, NA, NA, , South Africa, Other, No funding for study This trial does not have any financial costs and requires no funding, 43c Halton Road, London, , United Kingdom, Self Funded, No funding for study
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/07/2026 It was requested that I change the source to "self-funded" on feedback from PACTR This trial does not have any financial costs and requires no funding, 43c Halton Road, London, , United Kingdom, Self Funded, No funding for study This trial does not have any financial costs and requires no financial funding , 43c Halton Road, London, , United Kingdom, Self Funded, No funding for study
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/07/2026 No financial support - however the study is conducted as part of, and in addition to, routine clinical work This trial does not have any financial costs and requires no financial funding , 43c Halton Road, London, , United Kingdom, Self Funded, No funding for study Red Cross War Memorial Childrens Hospital, Klipfontein Rd, Cape Town, 7700, South Africa, Hospital, No funding for study
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/07/2026 Observational study - no financial support required - however the study is conducted as part of, and in addition to, routine clinical work at RCWMCH, thereby supported by RCWMCH. Any incidental costs paid for by Investigator Samson Kendall Samson Kendall, 43c Halton Road, London, N1 2EN, United Kingdom, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 09/07/2026 All patients must be under 18 years of age - error in writing maximum age of 18 in original submission 18 Year(s) 17 Year(s)