Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \>50% stenosis on CCTA, patients eligible for the study will be invited to participate. The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference. Patients will be divided into 2 sub-groups: Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography. Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography. In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care. Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Epicardial stenosis more than 50% by visual assessment.

Locations
Other Locations
Belgium
OLV Hospital Aalst
RECRUITING
Aalst
Contact Information
Primary
Sofie Pardaens, MSc, PhD
sofiepardaens@coreaalst.com
0032 53 72 42 30
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2031-10
Participants
Target number of participants: 250
Sponsors
Leads: CoreAalst BV
Collaborators: HeartFlow, Inc.

This content was sourced from clinicaltrials.gov