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

This study is currently recruiting participants.
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01739075
First received: November 27, 2012
Last updated: August 12, 2013
Last verified: August 2013

November 27, 2012
August 12, 2013
March 2012
April 2014   (final data collection date for primary outcome measure)
  • FFRct measurement [ Time Frame: Acute measurement ] [ Designated as safety issue: No ]
  • FFR measurement [ Time Frame: Acute assessment ] [ Designated as safety issue: No ]
  • FFRct measurement [ Time Frame: Will be performed after cCTA. cCTA is performed the day before ICA, and approximately one month after STEMI. ] [ Designated as safety issue: No ]
  • FFR measurement [ Time Frame: Performed during ICA ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01739075 on ClinicalTrials.gov Archive Site
Absolute regional myocardial perfusion [ Time Frame: Acute assessment ] [ Designated as safety issue: No ]
Assessed by cardiac Positron Emission Tomography (PET)
Absoulte regional myocardial perfusion [ Time Frame: The day before ICA, appoximately one month after STEMI ] [ Designated as safety issue: No ]
Assessed by cardiac Positron Emission Tomography (PET)
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Myocardial Ischemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sara Gaur, MD +45 78 45 22 50 sargau@rm.dk
Contact: Bjarne L Nørgaard, MD, Ph.D. bjarnoer@rm.dk
Denmark
 
NCT01739075
M-5-12
No
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Sara Gaur, MD Department of Cardiology, Aarhus University Hospital, Skejby
Study Chair: Bjarne L Nørgaard, MD, Ph.D. Department of Cardiology, Aarhus University Hospital, Skejby
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP