Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation

NCT05218694 | Unknown

• 1 other identifier: CT-FOCI01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

CCTA

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Stenosis in non-target vessel

  Through angiography completion, an average of 4-5 minuets. Timepoint 1

Study Arms (2)

CT-guided algorithm (CTGA)

EXPERIMENTAL

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.

Diagnostic Test: CCTA guided focused coronary angiography examination.

Standard treatment (ST)

NO INTERVENTION

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

Interventions

CCTA guided focused coronary angiography examination. DIAGNOSTIC_TEST

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

CT-guided algorithm (CTGA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Aarhus University Hospital, Depart. of Cardiology

Aarhus N, Central Region, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Nicolaj B Støttrup, MD, PH.D

CONTACT

+45 78450000; nicostoe@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Model Details: Patients (n=120) are randomized 1:1

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: February 1, 2022
• Study Start: May 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)