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

Completed

• Conditions: Coronary Artery Disease; Noninvasive Plaque Characterization

• Registration Number: NCT02030704
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac death	two years
Nonfatal myocardial infarction	two years

Secondary Outcome Measures

Name	Time	Method
Myocardial revascularization including PCI and CABG	two years	PCI - Percutaneous Coronary Intervention CABG - Coronary Artery Bypass Grafting

Trial Locations

Locations (2)

MTA-SE Lendület Cardiovascular Imaging Research Group, Heart and Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary

University of Heidelberg, Department of Cardiology; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany