National Plaque Registry and Database

Study Overview
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Brief Summary
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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
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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). To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics. To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value. Secondary goals: To develop a standardized and structured, national coronary CTA reporting system. To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.

Official Title
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National Plaque Registry and Database

Conditions
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Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Subject providing written informed consent Scheduled to undergo a clinically indicated coronary CTA Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary CT Angiography (CCTA)<br>Patients included in the OPeRA Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction |  | 10 years | 
| Unstable angina |  | 10 years | 
| Target vessel revascularization |  | 10 years | 
| CAD-related hospitalization |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease, Coronary Computed Tomographic Angiography, CCTA, Myocardial Infarction, MI, OPeRA