SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE

Recruiting

• Conditions: Ischemic Heart Disease; Heart Failure

• Registration Number: NCT06678802
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-08-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	0, 1 month, 6 months
NT-pro-BNP levels	0, 1 month, 6 months

Trial Locations

Locations (1)

Federico II University Hospital; 🇮🇹 Naples, Italy