Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation

NCT ID: NCT05218694

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-09-01

Brief 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.

Detailed Description

The study is a randomized, single center trial. Patients (n=120) referred for CCTA due to symptoms suggesting obstructive coronary disease (shortness of breath on exertion or angina in relation to activity), are randomized 1:1 if CCTA finds coronary lesions suggestive of obstructive coronary artery disease in at lest one vessel and thus indication for further investigation by invasive examination.

The patients are randomized to a standard treatment (ST) and a protocol with a CT-guided algorithm (CTGA) for optimal interventional work-flow. 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. Procedural time consumption (timepoint 1) is measured at the completion of the angiogram as specified (7.4.2). If there is a switch to a guiding catheter and subsequent coronary physiology test (fractional flow reserve [FFR]) this is marked at timepoint 2 at the conclusion of the FFR.

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.

On the day of invasive examination, the total amount of contrast, radiation dose, procedural time consumption and cost of utensils are registered as primary endpoints. In the conventional group, any significant stenosis in the non-target vessel

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CCTA guided focused coronary angiography examination.

Intervention Type: DIAGNOSTIC_TEST

Focused examination based on Images from CCTA, by choice of optimal catheter used and projection.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CCTA guided focused coronary angiography examination.

Focused examination based on Images from CCTA, by choice of optimal catheter used and projection.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Significant bleeding risk or other contraindications against heparinization or DAPT
• Known pregnancy
• Life expectancy < 120 days
• Patient unable to provide informed consent
• Patients with CTO (Chronic Total Occlusion).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Nicolaj Brejnholt Støttrup

MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital, Depart. of Cardiology

Aarhus N, Central Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nicolaj B Støttrup, MD, PH.D

Role: CONTACT

nicostoe@rm.dk

+45 78450000

Other Identifiers

CT-FOCI01

Identifier Type: -

Identifier Source: org_study_id