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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
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

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Homeland Defence Hospital
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
Pozitron Diagnostic Center
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryUnknown status
Markhot Ferenc Teaching Hospital and Clinic
Coordinator of this site? Confirm its status
EgerHungaryUnknown status
Petz Aladar County Teaching Hospital
Coordinator of this site? Confirm its status
GyőrHungaryUnknown status
Pándy Kálmán County Hospital
Coordinator of this site? Confirm its status
GyulaHungaryUnknown status
Health Centrum, Kaposvár University
Coordinator of this site? Confirm its status
KaposvárHungaryUnknown status
Borsod-Abaúj-Zemplén County Hospital and Teaching Hospital
Coordinator of this site? Confirm its status
MiskolcHungaryUnknown status
University of Pecs
Coordinator of this site? Confirm its status
PécsHungaryUnknown status
University of Szeged
Coordinator of this site? Confirm its status
SzegedHungaryUnknown status
Markusovszky Teaching Hospital
Coordinator of this site? Confirm its status
SzombathelyHungaryUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.