SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE (SENSITISE)

Federico II University

Status: Enrolling

Conditions: Ischemic Heart Disease; Heart Failure

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06678802

273/2023

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

450 participants in 3 patient groups

1 - Chronic ischemic heart disease

Treatment:

Other: Blood sampling

2 - Acute coronary syndromes

Treatment:

Other: Blood sampling

3 - Healthy volunteers

Treatment:

Other: Blood sampling