National Plaque Registry and Database
- Conditions
- AtherosclerosisCoronary Artery DiseaseCardiovascular Disease
- Registration Number
- NCT02578355
- Lead Sponsor
- Semmelweis University Heart and Vascular Center
- Brief Summary
The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction.
Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death.
The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.
- Detailed Description
The primary goals of OPeRA consortium:
To develop a national coronary CTA registry with the collaboration of all major cardiac CT centers of Hungary (Országos Plaque Regiszter és Adatbázis - NatiOnal Plaque Registry and DAtabase, OPeRA).
1. To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
2. To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.
Secondary goals:
1. To develop a standardized and structured, national coronary CTA reporting system.
2. To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- Age > 18 years
- Subject providing written informed consent
- Scheduled to undergo a clinically indicated coronary CTA
- Age <18 years
- Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- Recent prior myocardial infarction within 30 days prior to coronary CTA or between coronary CTA and ICA
- Pregnancy or unknown pregnancy status in subject of childbearing potential
- Subject requires an emergent procedure
- Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
- Inability to comply with study procedures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause death 10 years
- Secondary Outcome Measures
Name Time Method Myocardial infarction 10 years Target vessel revascularization 10 years CAD-related hospitalization 10 years Unstable angina 10 years
Trial Locations
- Locations (11)
University of Szeged
🇭🇺Szeged, Csongrád, Hungary
Petz Aladár County Teaching Hospital
🇭🇺Győr, Győr-Moson-Sopron, Hungary
University of Pécs
🇭🇺Pécs, Baranya, Hungary
Pozitron Diagnostic Center
🇭🇺Budapest, Hungary
Markhot Ferenc Teaching Hospital and Clinic
🇭🇺Eger, Heves, Hungary
Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
🇭🇺Miskolc, Borsod-Abaúj-Zenpén, Hungary
Pándy Kálmán County Hospital
🇭🇺Gyula, Békés, Hungary
Homeland Defence Hospital
🇭🇺Budapest, Pest, Hungary
Health Centrum, Kaposvár University
🇭🇺Kaposvár, Somogy, Hungary
Markusovszky Teaching Hospital
🇭🇺Szombathely, Vas, Hungary
University of Debrecen
🇭🇺Debrecen, Hajdú-Bihar, Hungary