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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Cardiology, Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with STEMI admitted at Aarhus Universtity Hospital and treated with primary PCI, and where the operater finds one or more residual stenoses in non-culprit vessels that needs to be assessed at a later time with ICA and FFR.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FFRct measurement	Acute measurement
FFR measurement	Acute assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute regional myocardial perfusion	Assessed by cardiac Positron Emission Tomography (PET)	Acute assessment

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Sara Gaur, MD, Aarhus University Hospital; Study Chair: Bjarne L Nørgaard, MD, Ph.D., Aarhus University Hospital

Publications and helpful links

General Publications

• Gaur S, Taylor CA, Jensen JM, Botker HE, Christiansen EH, Kaltoft AK, Holm NR, Leipsic J, Zarins CK, Achenbach S, Khem S, Wilk A, Bezerra HG, Lassen JF, Norgaard BL. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent STEMI. JACC Cardiovasc Imaging. 2017 Apr;10(4):424-433. doi: 10.1016/j.jcmg.2016.05.019. Epub 2016 Oct 12.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Stenosis
• Other Study ID Numbers: M-5-12