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.: PACTR202407499235154 Date of Registration: 31/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cardiflo: Effectiveness of Cardiflo in the screening of carotid stenosis in patients with clinical symptoms of cardiovascular disease at a tertiary hospital in Cape Town: a screening randomised controlled trial
Official scientific title Cardiflo: Effectiveness of Cardiflo in the screening of carotid stenosis in patients with clinical symptoms of cardiovascular disease at a tertiary hospital in Cape Town: a screening randomised controlled trial
Brief summary describing the background and objectives of the trial The CSIR has developed Cardiflo, a portable non-imaging Doppler ultrasound screening device that is adapted to screen patients at risk of cardiovascular events. This is done by performing Doppler flow measurements on the carotid arteries (common, internal, and external carotid arteries) using the device, together with customized software on a computer. The build-up of plaque on the inner walls of blood vessels is an important cardiovascular problem. The plaque will cause a narrowing (called stenosis) of affected blood vessels. Blood flowing through the narrowed section of an artery will tend to squirt through, that is it speeds up when the heart contracts to pump blood. This increased velocity is detectable by Doppler ultrasonography. Cardiflo targets the common carotid artery to identify such flow disruptions and uses the data obtained to calculate resistive indices. Cardiflo is a point-of-care (POC) screening device that provides faster results, is cheaper, safer, less invasive and less uncomfortable than most cardiovascular disease (CVD) investigative techniques used in current practice, and can be self-sampled. The objective of this study is to determine the efficacy of Cardiflo, a doppler ultrasound screening device, in screening patients with cardiovascular disease for carotid stenosis and improving disease outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Cardiflo
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
8162023 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
DOH270520246592 South African National Clinical Trials Registry
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cardiflo device once-off once-off Cardiflo screening risk of cardiovascular events 600
Control Group SOC n/a - standard of care n/a - standard of care n/a - standard of care 600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male or female, age ≥18 years at the time of signing informed consent. 3. LDL ≥ 190 mg/dl •ASCVD >10 if LDL ≥70 mg/dL (as per ACC/AHA guidelines) triglycerides >500 mg/dl 4. ASCVD risk score <7.5% with LDL < 190 mg/dl OR •ASCVD risk score 7.5-10% with LDL < 160 mg/dl OR •ASCVD risk score 10-15% with LDL <130 mg/dl 5. History of clinical ASCVD (heart attack, stroke) as per by 2013 ACC/AHA Cholesterol Guidelines 6. At least one of the below conditions (a-d): a) Coronary heart disease defined as at least one of the following: I. Prior myocardial infarction II. Prior coronary revascularisation procedure III. ≥50% stenosis in coronary artery documented by cardiac catheterisation or CT IV. coronary angiography V. Coronary heart disease with ischaemia documented by stress test with any VI. imaging modality b) Cerebrovascular disease defined as at least one of the following: I. Prior stroke II. Prior carotid artery revascularisation procedure III. ≥50% stenosis in carotid artery documented by X-ray angiography, MR IV. angiography, CT angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: I. Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest II. Intermittent claudication with a ≥50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound III. Prior peripheral artery (excluding carotid) revascularization procedure IV. Lower extremity amputation at or above ankle due to atherosclerotic disease V. (Excluding e.g., trauma or osteomyelitis) d) Chronic kidney disease defined as: eGFR < 60 mL/min/1.73 m2 1. Pregnancy, breastfeeding, or refusal to use contraception (for women of reproductive potential). 2. Knowledge or suspicion of pregnancy 3. Vasoactive medication (e.g., nitro) during the 12 hours prior to the exam 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 05/02/2024 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital Main Road, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Retention in care 12 and 36 months post intervention
Secondary Outcome 2) Incidence of MACE (major adverse cardiovascular events such as MI, stroke, cardiovascular death) 12 and 36 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Groote Schuur Hospital, Main Road, Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Council for Scientific and Industrial Research Stellenbosch Central Stellenbosch 7600 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Council for Scientific and Industrial Research Stellenbosch Central Stellenbosch 7600 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ntobeko Ntusi ntobeko.ntusi@mrc.ac.za +27214066200 Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Ntobeko Ntusi ntobeko.ntusi@mrc.ac.za +27214066200 Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Mathilda Mennen mathilda.mennen@uct.ac.za +27214066200 Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Study Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes UCT will share the summary findings of the trial publicly. Requests for access to the IPD (raw data) will be considered on a case-by-case basis by the PI and in consultation with the ethics committee. Study Protocol UCT will share the findings of the trial publicly within 6 months to a year. None
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 Official scientific title 29/07/2024 PACTR Admin Cardiflo: Effectiveness of Cardiflo in the screening of carotid stenosis in patients with clinical symptoms of cardiovascular disease at a tertiary hospital in Cape Town: a screening randomised controlled trial Cardiflo: Effectiveness of Cardiflo in the screening of carotid stenosis in patients with clinical symptoms of cardiovascular disease at a tertiary hospital in Cape Town: a screening randomised controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/05/2025 The study has been terminated prematurely on the grounds of futility. As outlined in our study protocol, the study’s primary objective was to identify patients with carotid stenosis using the Cardiflo hand-held Doppler screening device and to facilitate their linkage to care, with the aim of reducing major adverse cardiovascular events over time. However, the Cardiflo device demonstrated an unacceptably high false positive rate in diagnosing carotid stenosis. Not yet recruiting Stopped early/ terminated
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 29/07/2024 As requested by reviewer Primary Outcome, 1) Retention in care, 12 and 36 months Primary Outcome, 1) Retention in care, 12 and 36 months post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 29/07/2024 As requested by reviewer Secondary Outcome, 2) Incidence of MACE (major adverse cardiovascular events such as MI, stroke, cardiovascular death), 12 and 36 months Secondary Outcome, 2) Incidence of MACE (major adverse cardiovascular events such as MI, stroke, cardiovascular death), 12 and 36 months post intervention
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 29/07/2024 As requested by reviewer. UCT will share the findings of the trial publicly. Requests for access to the raw data will be considered on a case-by-case basis by the PI and in consultation with the ethics committee. UCT will share the summary findings of the trial publicly. Requests for access to the IPD (raw data) will be considered on a case-by-case basis by the PI and in consultation with the ethics committee.