Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score

Completed

• Conditions: Observational

• Registration Number: NCT03548753
• Lead Sponsor: Odense University Hospital

Brief Summary

A prospective, blinded multicenter study for evaluation of chest pain patients with severe coronary calcium (Agatston score \> 399). The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) is as effective as invasive coronary angiography (ICA) including functional flow reserve (FFR) for the detection and exclusion of obstructive coronary artery disease (CAD). Study hypothesis: initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy.

Detailed Description

Prospective, blinded multicenter study evaluating the diagnostic performance of coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) for the detection and exclusion of significant obstructive coronary artery disease (CAD). The reference standard vil be invasive coronary angiography (ICA) including functional flow reserve (FFR). Patients referred for elective CCTA because of suspected stable CAD are considered. If the initial routine non-enhanced CT scan shows an Agatston score \> 399, the patient is eligible for study inclusion. Four sites in the region of Southern Denmark will participate (Odense University Hospital, Svendborg Hospital, Vejle Hospital and Esbjerg Hospital). A total of 278 patients will be included.

Study Timeline

• Study Start: 2016-09-02
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Study First Submitted: 2018-05-22
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-07
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Age ≥ 18 years
• An estimated likelihood for the presence of significant CAD between 15% and 85%
• Clinical stable patients with symptoms of suspected CAD referred for CTTA
• Initial routine non-enhanced CT scan shows an Agatston score >399
• Written informed consent
• Accept to undergo elective invasive coronary angiography (ICA) within 90 days

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Exclusion Criteria

• Known prior myocardial infarction
• Prior percutaneous coronary intervention (PCI)
• Prior coronary artery bypass surgery (CABG)
• Pacemaker or internal defibrillator lead implantation
• Prosthetic heart valve
• Atrial fibrillation
• Renal Insufficiency (<40 mL/min)
• Known anaphylactic reaction to iodinated contrast
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR)	Comparison of the noninvasive and invasive diagnostic modalities is performed at least 90 days after enrollment of each of the included patients	The primary outcome measure is the per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR), which is considered the gold standard in the detection or exclusion of obstructive coronary artery disease (CAD)

Secondary Outcome Measures

Name	Time	Method
Invasive coronary angiography (ICA) including functional flow ratio (FFR) without obstructive coronary artery disease	90 days after inclusion	Percentage of patients with invasive coronary angiography (ICA) including functional flow reserve (FFR) measurement without evidence of obstructive coronary artery disease
Coronary revascularization procedures	90 day after inclusion	Percentage of coronary revascularization procedures (PCI and CABG) in patients with reduced FFR-CT vs. patients with normal FFR-CT
Other clinical endpoints	90 days after inclusion	Percentage of patients with the composite endpoint of all-cause mortality or myocardial infarction or unstable angina hospitalization
Major complications from diagnostic invasive diagnostic procedures	Within 72 hours after invasive procedure	Percentage of patients with major complications following invasive coronary angiography (ICA) including fractional flow reserve (FFR) measurement
Per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value	At least 90 days after patient inclusion	Assessing per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value
Per-vessel correlation of FFR-CT numerical value with the FFR numerical value in patients undergoing FFR	At least 90 days after patient inclusion	The per-vessel correlation of FFRCT numerical value with the FFR numerical value in patients undergoing FFR
The diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score vs. patients with very high calcium score	At least 90 days after patient inclusion	Comparison of the diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score (Agatston score 400-999) vs patients with very high calcium score (Agatston score ≥ 999)
Costs and resource use.	90 days after inclusion	Estimating the total costs of potentially unnecessary invasive coronary angiographies with functional flow ratio measurements

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Odense C, Denmark