National Plaque Registry and Database

Coronary Artery Disease Clinical Trial

— OPeRA  

Official title:

National Plaque Registry and Database

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02578355
• Other study ID #: The OPeRA study
• Status: Not yet recruiting
• Phase: N/A
• First received: October 14, 2015
• Last updated: April 24, 2017
• Start date: September 2016
• Est. completion date: December 2030

Study information

• Verified date: April 2017
• Source: Semmelweis University Heart and Vascular Center
• Contact: Pál Maurovich-Horvat, MD, PhD, MPH
• Phone: +36206632485
• Email: p.maurovich-horvat[@]cirg.hu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Hungary	Homeland Defence Hospital	Budapest	Pest
Hungary	Pozitron Diagnostic Center	Budapest
Hungary	University of Debrecen	Debrecen	Hajdú-Bihar
Hungary	Markhot Ferenc Teaching Hospital and Clinic	Eger	Heves
Hungary	Petz Aladár County Teaching Hospital	Gyor	Gyor-Moson-Sopron
Hungary	Pándy Kálmán County Hospital	Gyula	Békés
Hungary	Health Centrum, Kaposvár University	Kaposvár	Somogy
Hungary	Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital	Miskolc	Borsod-Abaúj-Zenpén
Hungary	University of Pécs	Pécs	Baranya
Hungary	University of Szeged	Szeged	Csongrád
Hungary	Markusovszky Teaching Hospital	Szombathely	Vas

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	Hungarian Academy of Sciences

Country where clinical trial is conducted

Hungary, 

References & Publications (14)

Braunwald E. Epilogue: what do clinicians expect from imagers? J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C101-3. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S74-5. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Narula J, Strauss HW. The popcorn plaques. Nat Med. 2007 May;13(5):532-4. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause death		10 years
Secondary	Myocardial infarction		10 years
Secondary	Unstable angina		10 years
Secondary	Target vessel revascularization		10 years
Secondary	CAD-related hospitalization		10 years