Clinical trial NCT02578355: National Plaque Registry and Database
Official title: National Plaque Registry and Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atherosclerosis
Coronary Artery Disease
Cardiovascular Disease
Keywords: Atherosclerosis
Coronary Artery Disease
Cardiovascular Disease
Coronary Computed Tomographic Angiography
CCTA
Myocardial Infarction
MI
OPeRA
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Hungarian Academy of Sciences
First posted: 2015-10-16
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent clinically indicated coronary CTA are involved in the sudy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause death
timeFrame: 10 years
Secondary outcomes:
measure: Myocardial infarction
timeFrame: 10 years
measure: Unstable angina
timeFrame: 10 years
measure: Target vessel revascularization
timeFrame: 10 years
measure: CAD-related hospitalization
timeFrame: 10 years
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
state: Baranya
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
state: Borsod-Abaúj-Zenpén
city: Gyula
country: Hungary
facility: Pándy Kálmán County Hospital
state: Békés
city: Szeged
country: Hungary
facility: University of Szeged
state: Csongrád
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
state: Győr-Moson-Sopron
city: Debrecen
country: Hungary
facility: University of Debrecen
state: Hajdú-Bihar
city: Eger
country: Hungary
facility: Markhot Ferenc Teaching Hospital and Clinic
state: Heves
city: Budapest
country: Hungary
facility: Homeland Defence Hospital
state: Pest
city: Kaposvár
country: Hungary
facility: Health Centrum, Kaposvár University
state: Somogy
city: Szombathely
country: Hungary
facility: Markusovszky Teaching Hospital
state: Vas
city: Budapest
country: Hungary
facility: Pozitron Diagnostic Center
Study officials:
affiliation: Heart and Vascular Center, Smellweis University
name: Pál Maurovich-Horvat, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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