Assessment of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT01739075
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to determine whether a novel non-invasive method to estimate coronary blood flow (FFRct) is applicable to evaluate the functional significance of coronary stenoses in non-culprit vessels in a population of patients with recent STEMI (ST-elevation myocardial infarction) and multivessel disease. The diagnostic performance and reproducibility of FFRct as well as the qualitative and quantitative correlation between FFRct and the regional coronary blood flow will be examined.

Detailed Description

Coronary Computed Tomography Angiography (cCTA) is a non-invasive imaging modality that provides high-resolution images of coronary lesions. cCTA shows good diagnostic performance in detecting or excluding coronary artery stenoses, but the severity of the lesions is often overestimated. With invasive coronary angiography (ICA) the hemodynamic consequences of obstructive lesions can be estimated using Fractional Flow Reserve measurement (FFR). There is a good correlation between FFR and non-invasive ischemia tests such as stress echocardiography, exercise tolerance test or Single Photon Emission Computed Tomography (SPECT). Measurement of FFR during ICA represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. The major disadvantage of FFR is that it is an invasive measurement, and consequently there is a risk of complications. Recently a non-invasive method to determine FFR has been developed (FFRct). FFRct is performed using standard cCTA images, and is based on computational fluid dynamics. The hemodynamic consequence of stenotic lesions is determined at rest and under simulated condition of hyperemia.

Acute myocardial infarction (MI) is divided into STEMI and NSTEMI on the basis of ECG changes. In Denmark patients with STEMI are treated with primary percutaneous intervention (PPCI) of the culprit lesion. Any non-culprit lesions are typically assessed with FFR after 3-4 weeks.

Even though the rate of complications during ICA with FFR is low, these complications can be severe. Also the procedure is quite resource demanding. Thus it would be desirable if it in these patients could be non-invasively evaluated whether further revascularisation is indicated.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Status Verified: 2013-08
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Recent STEMI and indication for new ICA to assess non-culprit lesions

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Exclusion Criteria

• contraindications to adenosine
• allergy to contrast agent
• P-creatinine > 125 micromol/L
• atrial fibrillation
• age < 18 years
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FFRct measurement	Acute measurement
FFR measurement	Acute assessment

Secondary Outcome Measures

Name	Time	Method
Absolute regional myocardial perfusion	Acute assessment	Assessed by cardiac Positron Emission Tomography (PET)

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark