Condition 1: ST-segment elevation MI. Condition 2: Ischaemic Heart failure. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Heart failure
Conditions
Interventions
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
Sponsors
National institute for medical search development (NIMAD)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 an | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Raoufi
Tehran University of Medical Sciences
Outcome results
None listed