AtherosclerosisOPeRANCT02578355
National Plaque Registry and Database
An observational study of Atherosclerosis and Coronary Artery Disease, run by Semmelweis University Heart and Vascular Center at 11 sites in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease
- How many people
- 20,000 participants
- Where
- 11 sitesHungary
- Study dates
- Sep 2016to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent clinically indicated coronary CTA are involved in the sudy.
Who may be able to join
- Age > 18 years
- Subject providing written informed consent
- Scheduled to undergo a clinically indicated coronary CTA
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Hungary11 sites
Homeland Defence Hospital
Budapest, Pest County, 1134
Pozitron Diagnostic Center
Budapest, 1117
University of Debrecen
Debrecen, Hajdú-Bihar, 4032
Markhot Ferenc Teaching Hospital and Clinic
Eger, Heves County, 3300
Petz Aladár County Teaching Hospital
Győr, Győr-Moson-Sopron, 9023
Pándy Kálmán County Hospital
Gyula, Bekes County, 5700
Health Centrum, Kaposvár University
Kaposvár, Somogy County, 7400
Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
Miskolc, Borsod-Abaúj-Zenpén, 3526
University of Pécs
Pécs, Baranya, 7624
University of Szeged
Szeged, Csongrád megye, 6725
Markusovszky Teaching Hospital
Szombathely, Vas County, 9700
About this study
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.
Read the 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).
- To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
- To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.
Secondary goals:
- To develop a standardized and structured, national coronary CTA reporting system.
- To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.
- Keywords
- Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease, Coronary Computed Tomographic Angiography, CCTA, Myocardial Infarction, MI, OPeRA
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All cause death
Measured: 10 years
Secondary outcomes (4)
Myocardial infarction
Measured: 10 years
Unstable angina
Measured: 10 years
Target vessel revascularization
Measured: 10 years
CAD-related hospitalization
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hungarian Academy of Sciences
- Responsible party
- Principal investigator, Pál Maurovich-Horvat, Semmelweis University Heart and Vascular Center
- Investigators
- Pál Maurovich-Horvat, MD, PhD, MPH, Principal investigator, Heart and Vascular Center, Smellweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578355
- Sponsor's protocol ID
- The OPeRA study
- Acronym
- OPeRA
- Status last verified
- Apr 2017
- First submitted
- 14 Oct 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24014390Narula J, Strauss HW. The popcorn plaques. Nat Med. 2007 May;13(5):532-4. doi: 10.1038/nm0507-532. No abstract available.
PubMed 17479093Braunwald 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.
PubMed 16631504Goff 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.
PubMed 24222018Genders 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.
PubMed 22692650Libby 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.
PubMed 23697515Virmani 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.
PubMed 10807742Narula 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.
PubMed 18641603Maurovich-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.
PubMed 24755916Falk 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.
PubMed 23242196Maurovich-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.
PubMed 20129522Leipsic 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.
PubMed 25301040Maurovich-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.
PubMed 20394906Engel 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.
PubMed 23830607
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Plaque Registry and Database
- ClinicalTrials.gov ID
- NCT02578355
- Acronym / sponsor ID
- OPeRA / The OPeRA study
- Keywords
- Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease, Coronary Computed Tomographic Angiography, CCTA, Myocardial Infarction, MI, OPeRA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- Hungarian Academy of Sciences
- Study start
- Sep 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
- To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.
Secondary goals:
- To develop a standardized and structured, national coronary CTA reporting system.
- To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent clinically indicated coronary CTA are involved in the sudy.
Key inclusion criteria (3 listed)
- Age > 18 years
- Subject providing written informed consent
- Scheduled to undergo a clinically indicated coronary CTA
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause death
Time frame: 10 years
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Background: PubMed 24014390Nichols 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.
- Background: PubMed 17479093Narula J, Strauss HW. The popcorn plaques. Nat Med. 2007 May;13(5):532-4. doi: 10.1038/nm0507-532. No abstract available.
- Background: PubMed 16631504Braunwald 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.
- Background: PubMed 24222018Goff 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.
- Background: PubMed 22692650Genders 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.
- Background: PubMed 23697515Libby 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.
- Background: PubMed 10807742Virmani 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.
- Background: PubMed 18641603Narula 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.
- Background: PubMed 24755916Maurovich-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.
- Background: PubMed 23242196Falk 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.
- Background: PubMed 20129522Maurovich-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.
- Background: PubMed 25301040Leipsic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pál Maurovich-Horvat, MD, PhD, MPH principal investigator
Heart and Vascular Center, Smellweis University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Artery Disease, run by Semmelweis University Heart and Vascular Center at 11 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pál Maurovich-Horvat, MD, PhD, MPH (+36206632485, p.maurovich-horvat@cirg.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578355, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.