National Plaque Registry and Database (OPeRA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Cardiovascular Disease; Atherosclerosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Pál Maurovich-Horvat, MD, PhD, MPH; Phone Number: +36206632485; Email: p.maurovich-horvat@cirg.hu
• Study Contact Backup: Name: Klaudia Bikov; Phone Number: +36208256889; Email: office@cirg.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1117
    • Pozitron Diagnostic Center
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • University of Pécs
  • Borsod-Abaúj-Zenpén
    • Miskolc, Borsod-Abaúj-Zenpén, Hungary, 3526
      • Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
  • Békés
    • Gyula, Békés, Hungary, 5700
      • Pándy Kálmán County Hospital
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • University of Szeged
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9023
      • Petz Aladár County Teaching Hospital
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • University of Debrecen
  • Heves
    • Eger, Heves, Hungary, 3300
      • Markhot Ferenc Teaching Hospital and Clinic
  • Pest
    • Budapest, Pest, Hungary, 1134
      • Homeland Defence Hospital
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Health Centrum, Kaposvár University
  • Vas
    • Szombathely, Vas, Hungary, 9700
      • Markusovszky Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coronary CT Angiography (CCTA); Patients included in the OPeRA Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause death	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarction	10 years
Unstable angina	10 years
Target vessel revascularization	10 years
CAD-related hospitalization	10 years

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: Hungarian Academy of Sciences
• Investigators: Principal Investigator: Pál Maurovich-Horvat, MD, PhD, MPH, Heart and Vascular Center, Smellweis University

Publications and helpful links

General Publications

• Leipsic J, Abbara S, Achenbach S, Cury R, Earls JP, Mancini GJ, Nieman K, Pontone G, Raff GL. SCCT guidelines for the interpretation and reporting of coronary CT angiography: a report of the Society of Cardiovascular Computed Tomography Guidelines Committee. J Cardiovasc Comput Tomogr. 2014 Sep-Oct;8(5):342-58. doi: 10.1016/j.jcct.2014.07.003. Epub 2014 Jul 24. No abstract available.
• Maurovich-Horvat P, Ferencik M, Voros S, Merkely B, Hoffmann U. Comprehensive plaque assessment by coronary CT angiography. Nat Rev Cardiol. 2014 Jul;11(7):390-402. doi: 10.1038/nrcardio.2014.60. Epub 2014 Apr 22.
• Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1262-75. doi: 10.1161/01.atv.20.5.1262. No abstract available.
• Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S74-5.
• Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe: epidemiological update. Eur Heart J. 2013 Oct;34(39):3028-34. doi: 10.1093/eurheartj/eht356. Epub 2013 Sep 7.
• Narula J, Strauss HW. The popcorn plaques. Nat Med. 2007 May;13(5):532-4. doi: 10.1038/nm0507-532. No abstract available.
• Braunwald E. Epilogue: what do clinicians expect from imagers? J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C101-3. doi: 10.1016/j.jacc.2005.10.072. No abstract available.
• Genders TS, Steyerberg EW, Hunink MG, Nieman K, Galema TW, Mollet NR, de Feyter PJ, Krestin GP, Alkadhi H, Leschka S, Desbiolles L, Meijs MF, Cramer MJ, Knuuti J, Kajander S, Bogaert J, Goetschalckx K, Cademartiri F, Maffei E, Martini C, Seitun S, Aldrovandi A, Wildermuth S, Stinn B, Fornaro J, Feuchtner G, De Zordo T, Auer T, Plank F, Friedrich G, Pugliese F, Petersen SE, Davies LC, Schoepf UJ, Rowe GW, van Mieghem CA, van Driessche L, Sinitsyn V, Gopalan D, Nikolaou K, Bamberg F, Cury RC, Battle J, Maurovich-Horvat P, Bartykowszki A, Merkely B, Becker D, Hadamitzky M, Hausleiter J, Dewey M, Zimmermann E, Laule M. Prediction model to estimate presence of coronary artery disease: retrospective pooled analysis of existing cohorts. BMJ. 2012 Jun 12;344:e3485. doi: 10.1136/bmj.e3485.
• Libby P. Mechanisms of acute coronary syndromes and their implications for therapy. N Engl J Med. 2013 May 23;368(21):2004-13. doi: 10.1056/NEJMra1216063. No abstract available.
• Narula J, Garg P, Achenbach S, Motoyama S, Virmani R, Strauss HW. Arithmetic of vulnerable plaques for noninvasive imaging. Nat Clin Pract Cardiovasc Med. 2008 Aug;5 Suppl 2:S2-10. doi: 10.1038/ncpcardio1247.
• Falk E, Nakano M, Bentzon JF, Finn AV, Virmani R. Update on acute coronary syndromes: the pathologists' view. Eur Heart J. 2013 Mar;34(10):719-28. doi: 10.1093/eurheartj/ehs411. Epub 2012 Dec 13.
• Maurovich-Horvat P, Ferencik M, Bamberg F, Hoffmann U. Methods of plaque quantification and characterization by cardiac computed tomography. J Cardiovasc Comput Tomogr. 2009 Nov-Dec;3 Suppl 2:S91-8. doi: 10.1016/j.jcct.2009.10.012. Epub 2009 Oct 31.
• Maurovich-Horvat P, Hoffmann U, Vorpahl M, Nakano M, Virmani R, Alkadhi H. The napkin-ring sign: CT signature of high-risk coronary plaques? JACC Cardiovasc Imaging. 2010 Apr;3(4):440-4. doi: 10.1016/j.jcmg.2010.02.003. No abstract available.
• Engel LC, Lee AM, Seifarth H, Sidhu MS, Brady TJ, Hoffmann U, Ghoshhajra BB. Weekly dose reports: the effects of a continuous quality improvement initiative on coronary computed tomography angiography radiation doses at a tertiary medical center. Acad Radiol. 2013 Aug;20(8):1015-23. doi: 10.1016/j.acra.2013.04.012.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiovascular Disease; Atherosclerosis; Myocardial Infarction; MI; CCTA; Coronary Computed Tomographic Angiography; OPeRA
• Additional Relevant MeSH Terms: Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: The OPeRA study