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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208834230748 Date of Approval: 15/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Therapeutic effect of early cardiac rehabilitation combined with melatonin supplementation after acute myocardial infarction treated by primary percutaneous coronary intervention.
Official scientific title Chronic effect of early cardiac rehabilitation combined with melatonin supplementation on myocardial function, aerobic capacity, endothelial function, oxidative stress, autonomic cardiac function and sleep quality in patients with acute myocardial infarction treated by primary percutaneous coronary intervention.
Brief summary describing the background and objectives of the trial Myocardial infarction (MI), happens when one or more areas of the heart muscle don't get enough oxygen which is most often caused by plaque rupture with thrombus formation in an epicardial coronary artery, resulting in an acute reduction of blood supply to a portion of the myocardium. Patients with acute myocardial infarction (AMI) following primary percutaneous coronary intervention have a reduced exercise capacity with a low value of VO2 peak which is related to a reduced cardiac output ,a mitochondrial dysfunction and an endothelial dysfunction generated by the increase of reactive oxygen species (ROS) due to the sudden reintroduction of oxygen . In addition, the excessive production of ROS after reperfusion can aggravate the cardiac dysfunction caused by the myocardial cell death. After MI, there is an imbalance in cardiac autonomic modulation characterized by an increase of the sympathetic system and a decrease of the parasympathetic system. Furthermore, sleep disturbances observed in people suffering from coronary artery diseases are due to the circadian misalignment by the decrease in nocturnal concentrations of melatonin, a neurohormone that regulates the biological clock. Moreover, this hormone has a cardioprotective effect due to its to its antioxidative, antiapoptotic, and anti-inflammatory actions. Early cardiac rehabilitation started within one month after discharge is an effective therapy and plays a key role in the management of patients with MI which may alleviate impairment in aerobic capacity, cardiovascular dysfunction, quality of sleep, autonomic cardiac dysfunction and oxidative stress.This is the first prospective study that investigate the chronic effect (12 weeks ) of early cardiorespiratory rehabilitation combined with melatonin supplementation in patients post AMI
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 01/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Evaluation without cardiac rehabilitation and melatonin suppelmentation 10 mg of placebo per night From 2 weeks to 14 weeks after hospital discharge (12 weeks) This group will not be subjected to any cardiac rehabilitation program and melatonin supplementation throughout the period of the experimentation and will undergo only the evaluation tests with daily ingestion of placebo (10 mg per nigth). 10 Placebo
Experimental Group Cardiac rehabilitation combined with melatonin supplementation Cardiac rehabilitation : 3 sessions/week A daily 10 mg of melatonin 12 weeks Patients of this group will be included of cardiac rehabilitation program combined with 10 mg of melatonin supplementation during 12 weeks. 10
Experimental Group Cardiac rehabilitation combined with placebo supplementation Cardiac rehabilitation : 3 sessions/ week Placebo supplementation : a daily 10 mg of placebo during 12 weeks 12 weeks Patients of this group will be included of cardiac rehabilitation program combined with 10 mg of placebop supplementation during 12 weeks. 10
Experimental Group melatoning supplementation A daily 10 mg of melatonin supplementation 12 weeks This group will not be subjected to any cardiac rehabilitation program throughout the period of the experimentation and will undergo only the evaluation tests with daily 10 mg of melatonin during 12 weeks 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A recent MI treated by primary percutaneous coronary intervention Chronic heart failure with left ventricular ejection fraction < 45% before the acute MI Recent valve surgery Musculoskeletal limitation Uncontrolled arrhythmia, hypertension, diabetes, or additional issues that would preclude potential participation in the program Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 26/05/2021 COMITE DE PROTECTION DES PERSONNES SUD
Ethics Committee Address
Street address City Postal code Country
Bd Majida Boulila Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Aerobic capacity measured by VO2 peak and 6 minute walk test , sleep quality evaluated by Spiegel questionnaire and actigraphy,myocardial function evaluated by Left Ventricule Ejection Fraction,autonomic cardiac function evaluated by heart rate variability, total antioxidant capacity Before and after intervention
Secondary Outcome Level of physical activity evaluated by International Physical Activity Questionnaire and Ricci Gagnon, Body Mass Index , Maximal Heart Rate , Systolic and diastolic blood pressure, Quality of life evaluated by Minnestosa Living With Heart Failure Questionnaire Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of Cardiology University Hospital Center Hedi Chaker Road el Ain Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Cardiology Hedi Chaker University Hospital Road Ain km 0.5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of cardiology University Hospital Hedi Chaker Road el Ain Km 0.5 Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Mona Turki Road Ain km 0.5 Sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ali Hbaieb mohamed.ali.hbaieb@univ-poitiers.fr +21694660000 Road Tunis Km 5
City Postal code Country Position/Affiliation
Sfax 3021 Tunisia PhD Student at University of Poitiers MOVE laboratory UR 20296
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda omar.hammouda@parisnanterre.fr +33782931995 Avenue of the Republic
City Postal code Country Position/Affiliation
Paris 92000 France Interdisciplinary Laboratory in Neurosciences Physiology and Psychology Physical Activity Health and Learning
Role Name Email Phone Street address
Scientific Enquiries Tarak Driss tarak.driss@parisnanterre.fr +33636414400 Avenue of the Republic
City Postal code Country Position/Affiliation
Paris 92000 France Interdisciplinary Laboratory in Neurosciences Physiology and Psychology Physical Activity Health and Learning
Role Name Email Phone Street address
Scientific Enquiries Laurent Bosquet laurent.bosquet@univ-poitiers.fr +33549454115 15 Rue Hotel dieu
City Postal code Country Position/Affiliation
Poitiers 86000 France MOVE laboratory UR 20296
Role Name Email Phone Street address
Scientific Enquiries Salma Charfeddine selma_charfeddine@yahoo.fr +21698638435 Road el Ain Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of cardiology University Hospital Hedi Chaker
Role Name Email Phone Street address
Public Enquiries Mohamed Ali Hbaieb mohamed.ali.hbaieb@univ-poitiers.fr +21694660000 Road Tunis km 5
City Postal code Country Position/Affiliation
Sfax 3021 Tunisia PhD Student at University of Poitiers MOVE laboratory UR 20296
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the trial and after deidentification will be shared Informed Consent Form Data will be made available following publication. Access to data can be granted anyone who wishes to access it.
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