Heart Failure, Ischemic Heart Disease
Conditions
Brief summary
This is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, CCS) or 2) acute coronary syndromes (group 2, ACS), both undergoing coronary angiography and eventually coronary revascularization at the Department of Scienze Cardiovascolari, Diagnostica per Immagini ed Emergenze Cardiovascolari of Federico II University Hospital, Naples, Italy. Age and sex-matched healthy volunteers without known ischemic heart disease (group 3, Ctr) will also be included as a control group. At enrollment (time 0), and after 48 hours (time 48 h), 1 month (time 1mo) and 6 month-follow-up visits (time 6 mo), clinical evaluation, ECG, trans-thoracic echocardiography and blood sampling will be performed, to isolate peripheral blood mononuclear cells (PBMC) and perform standard blood tests. The enrolment phase will last 24 months, and will likely involve 450 patients distributed as follows, according to the number of patients annually referring to our University Hospital: 1. Group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization; 2. Group 2, n= 200 patients with ACS undergoing coronary angiography and eventually coronary revascularization ; 3. Group 3, n= 50, healthy volunteers.
Interventions
OTHERBlood sampling
blood sampling from peripheral vein
Sponsors
Federico II University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Group 1: History (\> 6 months) of ischemic heart disease (prior myocardial infarction, prior percutaneous coronary intervention, prior surgical revascularization) and clinical or imaging evidence of chronic moderate or severe myocardial ischemia Group 2: Patients with acute coronary syndromes at presentation including ST-elevation myocardial infarction, Non-ST elevation myocardial infarction, and unstable angina. Group 3: Healthy volunteers with no prior history of ischemic heart disease or clinical/imaging evidence of myocardial ischemia.
Exclusion criteria
Patients unwilling to provide informed consent to participate to the study * Concomitant primary cardiomyopathies or hemodynamically significant heart valve disease * Treatment with cancer or antibiotic therapies affecting ribosomal structure or function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction | 0, 1 month, 6 months |
| NT-pro-BNP levels | 0, 1 month, 6 months |
Countries
Italy
Contacts
Primary ContactCinzia Perrino, MD PhD
Backup ContactGiovanni Esposito
Outcome results
None listed