NCT02578355Not yet recruiting
National Plaque Registry and Database
Source: ClinicalTrials.gov · Last updated 25 Apr 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20000 (estimated)
- First submitted
- 14 Oct 2015
- Start date
- Sept 2016
- Primary completion date
- Dec 2030
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Diseases
- Coronary artery disease
- NCT number
- NCT02578355
What you commit to
- Study type: Observational
- Planned participants: 20000
- From Sept 2016 to the primary completion date, Dec 2030
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent prior myocardial infarction within 30 days prior to coronary CTA or between coronary CTA and ICA
Other illness
- Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- 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
Age
- Age \<18 years
Other
- Pregnancy or unknown pregnancy status in subject of childbearing potential
- Subject requires an emergent procedure
- Inability to comply with study procedures
Who the study is looking for
- Age \> 18 years
- Subject providing written informed consent
- Scheduled to undergo a clinically indicated coronary CTA
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Homeland Defence Hospital Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Pozitron Diagnostic Center Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Markhot Ferenc Teaching Hospital and Clinic Coordinator of this site? Confirm its status | Eger | Hungary | Unknown status |
| Petz Aladar County Teaching Hospital Coordinator of this site? Confirm its status | Győr | Hungary | Unknown status |
| Pándy Kálmán County Hospital Coordinator of this site? Confirm its status | Gyula | Hungary | Unknown status |
| Health Centrum, Kaposvár University Coordinator of this site? Confirm its status | Kaposvár | Hungary | Unknown status |
| Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital Coordinator of this site? Confirm its status | Miskolc | Hungary | Unknown status |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Markusovszky Teaching Hospital Coordinator of this site? Confirm its status | Szombathely | Hungary | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.