Skip to content

National Plaque Registry and Database

National Plaque Registry and Database

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02578355
Acronym
OPeRA
Enrollment
20000
Registered
2015-10-16
Start date
2016-09-30
Completion date
2030-12-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cardiovascular Disease, Coronary Artery Disease

Keywords

Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease, Coronary Computed Tomographic Angiography, CCTA, Myocardial Infarction, MI, OPeRA

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.

Interventions

None listed

Sponsors

Hungarian Academy of Sciences
CollaboratorOTHER
Semmelweis University Heart and Vascular Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All cause death10 years

Secondary

MeasureTime frame
Myocardial infarction10 years
Unstable angina10 years
Target vessel revascularization10 years
CAD-related hospitalization10 years

Countries

Hungary

Contacts

Primary ContactPál Maurovich-Horvat, MD, PhD, MPH
p.maurovich-horvat@cirg.hu+36206632485
Backup ContactKlaudia Bikov
office@cirg.hu+36208256889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026