Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation

Coronary Artery Disease Clinical Trial

— CT-FOCI  

Official title:

Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218694
• Other study ID #: CT-FOCI01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Aarhus University Hospital Skejby
• Contact: Nicolaj B Støttrup, MD, PH.D
• Phone: +45 78450000
• Email: nicostoe[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CCTA guided focused coronary angiography examination.
Focused examination based on Images from CCTA, by choice of optimal catheter used and projection.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Depart. of Cardiology	Aarhus N	Central Region

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient radiation dose	After coronary angiography and percutaneous coronary intervention (PCI), the Dose Area Product (DAP) Gycm2 and the radiation time (MM:SS) is recorded.	Through angiography completion, an average of 4-5 minuets. Timepoint 1
Primary	Procedure time	The procedure time is defined at the time from first catheter insertion to final catheter removal. Time is recorded in MM:SS.	Through angiography completion, an average of 4-5 minuets. Timepoint 1
Primary	Contrast use	The amount of contrast medium used for examination and intervention is measured (ml) by weight measurements (gram = ml).	Through angiography completion, an average of 4-5 minuets. Timepoint 1
Primary	utensils use	The use of utensils are logged and a cost estimate subsequently calculated on the basis of the current price list (DKK/USD).	Through angiography completion, an average of 4-5 minuets. Timepoint 1
Secondary	Stenosis in non-target vessel	Significant stenosis in non-target vessel, (only conventional grope), confirmed by FFR <0.80	Through angiography completion, an average of 4-5 minuets. Timepoint 1