Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation (CT-FOCI)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Central Region
-
Aarhus N, Central Region, Denmark, 8200
- Aarhus University Hospital, Depart. of Cardiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Focused examination based on Images from CCTA, by choice of optimal catheter used and projection.
|
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient radiation dose
Time Frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
|
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
Time Frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
|
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
Time Frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
|
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
Time Frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stenosis in non-target vessel
Time Frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-FOCI01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.