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NCT Number: NCT02578355

National Plaque Registry and Database

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pécs, Pécs, Baranya, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Klaudia Bikov

CONTACT

[email protected]

+36208256889

Pál Maurovich-Horvat, MD, PhD, MPH

CONTACT

[email protected]

+36206632485

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Collaborators

  • Hungarian Academy of Sciences

Registry information

Acronym: OPeRA

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Oct 16, 2015
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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