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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

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 64 participants
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.
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. FFRct measurement [ Time Frame: Acute measurement ]
  2. FFR measurement [ Time Frame: Acute assessment ]

Secondary Outcome Measures :
  1. Absolute regional myocardial perfusion [ Time Frame: Acute assessment ]
    Assessed by cardiac Positron Emission Tomography (PET)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Aarhus University Hospital
Study Chair: Bjarne L Nørgaard, MD, Ph.D. Aarhus University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01739075     History of Changes
Other Study ID Numbers: M-5-12
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: August 2013

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Coronary Stenosis
Pathologic Processes
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases