CCTA-based Coronary Plaque Characterization and High-sensitive Troponin T for the Prediction of Cardiovascular Outcomes

September 10, 2018 updated by: GKorosoglou, University Hospital Heidelberg

Comprehensive 'Bio-Imaging' Using Quantitative Coronary Plaque Composition Assessment and the High-sensitive Troponin T for the Prediction of Cardiac Outcomes.

To determine the ability of semi-automated plaque assessment in cardiac computed tomography angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of patients at intermediate risk for coronary artery disease (CAD).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • University of Heidelberg, Department of Cardiology
  • Hungary
      • Budapest, Hungary, 1122
        • MTA-SE Lendület Cardiovascular Imaging Research Group, Heart and Vascular Center, Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients scheduled to undergo CCTA

Description

Inclusion Criteria:

  • Clinical indication for CCTA according to the current appropriate use criteria

Exclusion Criteria:

  • non-sinus rhythm
  • acute coronary syndromes
  • cardiomyopathies
  • moderate or severe valvular disease
  • elevated serum creatinine (>1.5 mg/dl)
  • history or ECG signs of previous myocardial infarction
  • severe iodine allergy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Atherosclerotic Plaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: two years
two years
Nonfatal myocardial infarction
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial revascularization including PCI and CABG
Time Frame: two years
PCI - Percutaneous Coronary Intervention CABG - Coronary Artery Bypass Grafting
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Heidelberg University
Semmelweis University Heart and Vascular Center

Investigators

  • Principal Investigator: Grigorios Korosoglou, Prof. Dr. med., University of Heidelberg, Department of Cardiology, Heidelberg, Germany.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDCCTA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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