National Plaque Registry and Database

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSemmelweis University Heart and Vascular Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Subject providing written informed consent

Scheduled to undergo a clinically indicated coronary CTA

Disqualifiers

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

Trial population

Patients who underwent clinically indicated coronary CTA are involved in the sudy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20,000 Participants
are grouped into 1 trial group
Group A: Coronary CT Angiography (CCTA)

Trial outcomes

Primary outcomes

1

All cause death

Time frame
10 years

Secondary outcomes

1

Myocardial infarction

Time frame
10 years
2

Unstable angina

Time frame
10 years
3

Target vessel revascularization

Time frame
10 years
4

CAD-related hospitalization

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University Heart and Vascular Center

Lead sponsor

Hungarian Academy of Sciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: