National Plaque Registry and Database

Overview

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.

Primary outcome measures

• All cause death [Time frame: 10 years]

Secondary outcome measures (4)

• Myocardial infarction [Time frame: 10 years]
• Unstable angina [Time frame: 10 years]
• Target vessel revascularization [Time frame: 10 years]
• CAD-related hospitalization [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Hungary · 11 centers

• University of Pécs — Pécs
• Pándy Kálmán County Hospital — Gyula
• Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital — Miskolc
• University of Szeged — Szeged
• Petz Aladár County Teaching Hospital — Győr
• University of Debrecen — Debrecen
• Markhot Ferenc Teaching Hospital and Clinic — Eger
• Homeland Defence Hospital — Budapest
• … and 3 more centers

Publications

• 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. PMID 24014390
• Narula J, Strauss HW. The popcorn plaques. Nat Med. 2007 May;13(5):532-4. doi: 10.1038/nm0507-532. No abstract available. PMID 17479093
• 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. PMID 16631504
• 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 G PMID 24222018
• 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, R PMID 22692650
• 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. PMID 23697515
• 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. PMID 10807742
• 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. PMID 18641603

Identifiers

NCT: NCT02578355 · The OPeRA study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗