SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemic Heart Disease Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1 - Chronic ischemic heart disease

Blood sampling

Intervention Type OTHER

blood sampling from peripheral vein

2 - Acute coronary syndromes

Blood sampling

Intervention Type OTHER

blood sampling from peripheral vein

3 - Healthy volunteers

Blood sampling

Intervention Type OTHER

blood sampling from peripheral vein

Interventions

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Blood sampling

blood sampling from peripheral vein

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes