Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02578355
Study type Observational [Patient Registry]
Source Semmelweis University Heart and Vascular Center
Contact Pál Maurovich-Horvat, MD, PhD, MPH
Phone +36206632485
Email p.maurovich-horvat@cirg.hu
Status Not yet recruiting
Phase N/A
Start date September 2016
Completion date December 2030

See also
  Status Clinical Trial Phase
Completed NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT03226262 - FFRangio Accuracy vs. Standard FFR
Recruiting NCT03552432 - The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography Phase 4
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03427749 - Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
Not yet recruiting NCT03620539 - Sauna Bathing to Improve Vascular Health of Adults With Heart Disease N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT03518437 - Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Active, not recruiting NCT02693158 - The Direct III Post Market Study
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A