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IRCT20210827052304N1 IRCT 2022-09-12 National institute for medical search development (NIMAD) Evaluation of the safety and feasibility of FSTL-1 cardiac patch Evaluating the safety and feasibility of collagen patch loaded with epicardial follistatin-like 1 (FSTL1) for treatment of myocardial ischemic injury 2018-09-26 anticipated 9 Complete https://irct.ir/trial/65011 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Condition 1: ST-segment elevation MI. Condition 2: Ischaemic Heart failure. Intervention group: Acellular collagen patch (E = 10 kilopascal) fabricated through plastic compression and loaded with 10 micro grams of recombinant bacterial-synthetized human follistatin like 1 per patch which is grafter to the infarct area through coronary artery bypass surgery. Patches were purified using High performance liquid chromatography (HPLC) test and endotoxin test was performed on patches.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Our team wants to decide this matter at the time of publishing the article
public Mohammad Raoufi
16th Azar Ave, Enghelab Sq.
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ ۶۴۱۲۰ - (۰۲۱) mraoufib@gmail.com Tehran University of Medical Sciences scientific Mohammad Raoufi
16th Azar Ave, Enghelab Sq.
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ ۶۴۱۲۰ - (۰۲۱) mraoufib@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 80 years old The first-time episode of myocardial infarction (MI) ST-elevation on the patient's electrocardiogram (ECG) Recommendation of isolated coronary artery bypass (CABG) by treating cardiologists or cardiac surgeons after conducting coronary angiography Less than 3 months delay between MI and upcoming operation Ejection fraction ≥ 20% and ≤ 40% Ischemia (rather than other cardiac problems) causing heart failure No planning for pregnancy during the study period for female participants 18 years 80 years Both Previous history of constrictive pericarditis Past history of surgery on pericardium Pregnancy Being on immunosuppressive therapy Corticosteroid medications, or chemotherapy (or any plan for being on such treatments within the next 6 months after recruitment) Current or past history of cancer Current or previous history of autoimmune disorders Severe renal disorder (glomerular filtration rate < 60 ml/min/1.73 m2 Being a candidate for any types of cardiac surgery concomitant with coronary artery bypass surgery Having malignant ventricular arrhythmia or atrial flutter Severe mitral valve stenosis or insufficiency Severe aortic valve stenosis or insufficiency Patients with poor echo views Severe hepatic failure or cirrhosis Estimated life expectancy of less than one year Previous history for undergoing cardiac surgery Any contraindication for conducting cardiac magnetic resonance image Any tendency for perioperative bleeding (international normalized ratio > 1.5) Having pulmonary disease with forced expiratory volume < 50% or diffusing capacity of the lungs for carbon monoxide < 50% Having dementia, Alzheimer, Parkinsonism, and/or previous stroke with physical secuela. I21 I50 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Heart failure Treatment - Surgery Intervention group: Acellular collagen patch (E = 10 kilopascal) fabricated through plastic compression and loaded with 10 micro grams of recombinant bacterial-synthetized human follistatin like 1 per patch which is grafter to the infarct area through coronary artery bypass surgery. Patches were purified using High performance liquid chromatography (HPLC) test and endotoxin test was performed on patches. Stiffness of the patch. Timepoint: Before and during the surgery. Method of measurement: Assessment of surgeons and bio-engineers of the patches outside the patients body and inside during surgery. Suturablity of the patch. Timepoint: Before and during surgery. Method of measurement: Assessment of surgeons and bio-engineers of the patches outside the patients body and inside during surgery. Death. Timepoint: During surgery and until 6 months post-operatively. Method of measurement: Physical examination. New acute myocardial infarction. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination, cardiac enzymes, echocardiograpghy, electrocardiogram. Allergic reaction. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination, laboratory tests. Patch rejection. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination, laboratory tests. New arrhythmia. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking, electrocardiography , echocardiography. New significant pericardial effusion. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination , echocardiography. New cardiac tamponade. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination , echocardiography. New acute pericarditis. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking , physical examination , echocardiography. New drug-induced liver injury. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking, physical examination, liver function test. New acute renal injury. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking, physical examination, renal function test. Drug induced myelosupression. Timepoint: After operation and until 6 months post-operatively (before discharge, 1 month, 3 months and 6 months after surgery). Method of measurement: History taking, physical examination, CBC, if required : bone marrow aspiration. Left ventricular ejection fraction. Timepoint: Before and after surgery up until 6 months (before discharge, 1st, 3rd and 6th month after surgery). Method of measurement: Echocardiography, cardiac magnetic resonance imaging. Global longitudinal strain. Timepoint: Before and after surgery up until 6 months (before discharge, 1st, 3rd and 6th month after surgery). Method of measurement: Echocardiography. Myocardial extracellular volume. Timepoint: Before operation and 6 month post-operative. Method of measurement: cardiac magnetic resonance imaging. Native T1 mapping. Timepoint: Before operation and 6 month post-operative. Method of measurement: cardiac magnetic resonance imaging. National institute for medical search development (NIMAD) Approved 2016-12-26 Ethics committee of National Institute for Medical Research Development (NIMAD) National Institute of Medical Research Development of Iran (NIMAD), No. 21, at the beginning of Baath St., Fatemi West St., Tehran تهران Tehran Iran (Islamic Republic of)