NCT02578355

National Plaque Registry and Database

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Semmelweis University Heart and Vascular Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Coronary Artery Disease
• Cardiovascular Disease

Timeline

• Start date: 2016-09-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2015-10-16
• Last updated: 2017-04-25

Locations

11 sites across 1 country: Hungary