Clinical trial NCT06678802: SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE
Official title: ROLE OF CIRCULATING SMALL NUCLEOLAR RNA SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 0, 1 month, 6 months
measure: NT-pro-BNP levels
timeFrame: 0, 1 month, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University Hospital
Study officials:
References: