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

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ClinicalTrials.gov Identifier: NCT01739075
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date November 27, 2012
First Posted Date November 30, 2012
Last Update Posted Date June 2, 2014
Study Start Date March 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2013)
  • FFRct measurement [ Time Frame: Acute measurement ]
  • FFR measurement [ Time Frame: Acute assessment ]
Original Primary Outcome Measures
 (submitted: November 27, 2012)
  • FFRct measurement [ Time Frame: Will be performed after cCTA. cCTA is performed the day before ICA, and approximately one month after STEMI. ]
  • FFR measurement [ Time Frame: Performed during ICA ]
Change History
Current Secondary Outcome Measures
 (submitted: January 2, 2013)
Absolute regional myocardial perfusion [ Time Frame: Acute assessment ]
Assessed by cardiac Positron Emission Tomography (PET)
Original Secondary Outcome Measures
 (submitted: November 27, 2012)
Absoulte regional myocardial perfusion [ Time Frame: The day before ICA, appoximately one month after STEMI ]
Assessed by cardiac Positron Emission Tomography (PET)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.
Official Title Assessment of the Functional Significance of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Myocardial Ischemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Gaur S, Taylor CA, Jensen JM, Bøtker HE, Christiansen EH, Kaltoft AK, Holm NR, Leipsic J, Zarins CK, Achenbach S, Khem S, Wilk A, Bezerra HG, Lassen JF, Nørgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 30, 2014)
64
Original Estimated Enrollment
 (submitted: November 27, 2012)
60
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01739075
Other Study ID Numbers M-5-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Sara Gaur, MD Aarhus University Hospital
Study Chair: Bjarne L Nørgaard, MD, Ph.D. Aarhus University Hospital
PRS Account University of Aarhus
Verification Date August 2013