National Plaque Registry and Database

NCT02578355 | Not Yet Recruiting

• 1 other identifier: The OPeRA study
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Disease

Keywords

Atherosclerosis; Coronary Artery Disease; Cardiovascular Disease; Coronary Computed Tomographic Angiography; CCTA; Myocardial Infarction; MI; OPeRA

Outcome Measures

Primary Outcomes (1)

• All cause death

  10 years

Secondary Outcomes (4)

• Myocardial infarction

  10 years

• Unstable angina

  10 years

• Target vessel revascularization

  10 years

• CAD-related hospitalization

  10 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years
• Subject providing written informed consent
• Scheduled to undergo a clinically indicated coronary CTA

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• Hungarian Academy of Sciences: collaborator

Study Sites (11)

University of Pécs

Pécs, Baranya, 7624, Hungary

Location

Pándy Kálmán County Hospital

Gyula, Bekes County, 5700, Hungary

Location

Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital

Miskolc, Borsod-Abaúj-Zenpén, 3526, Hungary

Location

University of Szeged

Szeged, Csongrád megye, 6725, Hungary

Location

Petz Aladár County Teaching Hospital

Győr, Győr-Moson-Sopron, 9023, Hungary

Location

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Markhot Ferenc Teaching Hospital and Clinic

Eger, Heves County, 3300, Hungary

Location

Homeland Defence Hospital

Budapest, Pest County, 1134, Hungary

Location

Health Centrum, Kaposvár University

Kaposvár, Somogy County, 7400, Hungary

Location

Markusovszky Teaching Hospital

Szombathely, Vas County, 9700, Hungary

Location

Pozitron Diagnostic Center

Budapest, 1117, Hungary

Location

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 24222018 BACKGROUND

• 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.

  PMID: 22692650 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 24755916 BACKGROUND

• 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.

  PMID: 23242196 BACKGROUND

• 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.

  PMID: 20129522 BACKGROUND

• 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.

  PMID: 25301040 BACKGROUND

• 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.

  PMID: 20394906 BACKGROUND

• 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.

  PMID: 23830607 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Pál Maurovich-Horvat, MD, PhD, MPH

  Heart and Vascular Center, Smellweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pál Maurovich-Horvat, MD, PhD, MPH

CONTACT

+36206632485; p.maurovich-horvat@cirg.hu

Klaudia Bikov

CONTACT

+36208256889; office@cirg.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

HU (11)