Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Coronary computed tomography angiography (CCTA) is a non-invasive method for visualization of the coronary arteries. The anatomical information obtained by CCTA, however, is rarely integrated into a subsequent coronary intervention. The CT-FOCI trial aims to evaluate, in a randomized setting, the benefit of implementing the information obtained by CCTA as part of the invasive examination using a CT-guided algorithm (CTGA). Patients (n=120) with symptoms of stable angina pectoris will be randomized 1:1 after CCTA has determined at least 1 stenosis with luminal diameter reduction of minimum 50% in a vessel segment \> 2 mm in diameter. Subsequent, invasive examination and intervention will utilize the information available according to randomization. Primary efficacy endpoints are a reduction in patient radiation exposure, procedure time, procedural utensils, and contrast use. Secondary endpoints is significant stenosis in the non-target vessel, only available in the conventional group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age \> 18 and \< 81 years

• Stable angina

• at least 1 vessel disease in either the left coronary artery or right coronary artery

• Stenosis grater than 50% and no stenosis greater than 40% on contralateral vessel unless fractional flow reserve by CT (FFRct) \>0.80

• Vessel segment \> 2 mm in diameter

• Subject eligible for Dual Anti Platelet Therapy (DAPT

Locations
Other Locations
Denmark
Aarhus University Hospital, Depart. of Cardiology
RECRUITING
Aarhus N
Contact Information
Primary
Nicolaj B Støttrup, MD, PH.D
nicostoe@rm.dk
+45 78450000
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2024-09-01
Participants
Target number of participants: 120
Treatments
Experimental: CT-guided algorithm (CTGA)
In the CTGA group only the artery suspected of having obstructive coronary disease is examined. Anatomy of the vessel, optimal viewing projections and choice of catheter is determined. A guiding catheter is used as first choice based on the artery involved and the aortic anatomy. Time is recorded according to the ST group, with timepoint 1 after conclusion of the angiogram, timepoint 2 after FFR.
No_intervention: Standard treatment (ST)
ST includes the use of two diagnostic cathers and examination of both coronary arteries by at least 6 different standard projections best optimizing the view of the coronary lesions.~Additional projections may be included if deemed necessary for optimal angiographic evaluation
Sponsors
Leads: Aarhus University Hospital Skejby

This content was sourced from clinicaltrials.gov

Similar Clinical Trials