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Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2

NCT03481712 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1732

Last updated 2021-01-20

No results posted yet for this study

Summary

In a cohort of symptomatic patients referred to coronary computed tomography angiography (CCTA), the investigators aim:

1. To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography (Rb PET) and 3 Tesla Cardiac Magnetic Resonance imaging (3T CMRI) in patients where CCTA does not exclude significant coronary artery disease (CAD) using invasive coronary angiography with fractional flow reserve (ICA-FFR) as reference standard.
2. To evaluate the diagnostic precision of quantitative flow ratio (QFR) and ICA-FFR in patients where CCTA does not exclude significant CAD using Rb PET and 3T CMRI as reference standard.
3. To show superiority for the CADScor®System compared to the Diamond-Forrester score in detection of CAD with CCTA and ICA quantitative coronary angiography (ICA-QCA) as reference standard.
4. To study the diagnostic accuracy of computed tomography fractional flow reserve (CT-FFR) in patients where CCTA does not exclude significant CAD with ICA-FFR as reference standard.
5. To identify and characterize genetic risk variants´ and circulating biomarkers´ importance in developing CAD.
6. To evaluate the bone mineral density in the hip and spine and correlate this to the degree of vascular calcification.

Conditions

Interventions

DIAGNOSTIC_TEST

Diagnostic tests

Head-to-head comparison between: * CADScor and Diamond-Foster score * Rb PET and 3T CMRI * QFR and ICA-FFR

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Morten Böttcher, MD, Ph.D · Regional Hospital of Herning, department of cardiology

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2020-12-03
Completion
2020-12-03

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481712 on ClinicalTrials.gov