SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE

NCT06678802 | Recruiting

• 1 other identifier: 273/2023
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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. 1.Group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization;
2. 2.Group 2, n= 200 patients with ACS undergoing coronary angiography and eventually coronary revascularization ;
3. 3.Group 3, n= 50, healthy volunteers.

Conditions

Heart Failure; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• Left ventricular ejection fraction

  0, 1 month, 6 months

• NT-pro-BNP levels

  0, 1 month, 6 months

Study Arms (3)

1 - Chronic ischemic heart disease

Other: Blood sampling

2 - Acute coronary syndromes

Other: Blood sampling

3 - Healthy volunteers

Other: Blood sampling

Interventions

Blood sampling OTHER

blood sampling from peripheral vein

1 - Chronic ischemic heart disease; 2 - Acute coronary syndromes; 3 - Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Heart Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Cinzia Perrino, MD PhD

CONTACT

00390817462223; perrino@unina.it

Giovanni Esposito

CONTACT

00390817462223; cardiologiafedericoii@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: March 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: February 28, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)