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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01739075
First received: November 27, 2012
Last updated: May 30, 2014
Last verified: August 2013
History of Changes
  Purpose

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.


Condition
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Functional Significance of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • FFRct measurement [ Time Frame: Acute measurement ] [ Designated as safety issue: No ]
  • FFR measurement [ Time Frame: Acute assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute regional myocardial perfusion [ Time Frame: Acute assessment ] [ Designated as safety issue: No ]
    Assessed by cardiac Positron Emission Tomography (PET)
Enrollment: 64
Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739075

Locations
Denmark
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01739075     History of Changes
Other Study ID Numbers: M-5-12
Study First Received: November 27, 2012
Last Updated: May 30, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Coronary Stenosis
Myocardial Ischemia
Cardiovascular Diseases
 Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015