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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030704
• Other study ID #: HDCCTA01
• Status: Completed
• Start date: February 2008
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Noninvasive Plaque Characterization

Locations

Country	Name	City	State
Germany	University of Heidelberg, Department of Cardiology	Heidelberg	Baden-Wuerttemberg
Hungary	MTA-SE Lendület Cardiovascular Imaging Research Group, Heart and Vascular Center, Semmelweis University	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Heidelberg University, Semmelweis University Heart and Vascular Center

Countries where clinical trial is conducted

Germany,  Hungary, 

References & Publications (1)

Korosoglou G, Mueller D, Lehrke S, Steen H, Hosch W, Heye T, Kauczor HU, Giannitsis E, Katus HA. Quantitative assessment of stenosis severity and atherosclerotic plaque composition using 256-slice computed tomography. Eur Radiol. 2010 Aug;20(8):1841-50. doi: 10.1007/s00330-010-1753-3. Epub 2010 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death		two years
Primary	Nonfatal myocardial infarction		two years
Secondary	Myocardial revascularization including PCI and CABG	PCI - Percutaneous Coronary Intervention CABG - Coronary Artery Bypass Grafting	two years