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Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00281346
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : July 18, 2016
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Unstable Angina Pectoris Acute Myocardial Infarction Procedure: Doppler echocardiography Not Applicable

Detailed Description:

Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded evaluation of Doppler results and coronary angiography regarding the other examination modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study.

Added January 2007 after ethics committee approval: comparison of CFVR with invasive fractional flow reserve (FFR) in selected subset of patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
Study Start Date : December 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: transthoracic Doppler echocardiography Procedure: Doppler echocardiography

Primary Outcome Measures :
  1. Diagnostic yield: Accuracy, positive and negative predictive value. [ Time Frame: Inhospital ]
  2. pr patient evaluation [ Time Frame: Inhospital ]

Secondary Outcome Measures :
  1. pr stenosis evaluation [ Time Frame: Inhospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • unstable angina or acute myocardial infarction, or stable angina pectoris and
  • scheduled for coronary angiography on accepted clinical reasons

Exclusion Criteria:

  • past coronary artery grafting

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 identifier (NCT number): NCT00281346

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Ålesund Hospital HF
Ålesund, Norway, N-6026
Sponsors and Collaborators
Norwegian University of Science and Technology
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Study Chair: Torstein L Hole, MD, PhD Norwegian University of Science and Technology
Principal Investigator: Johnny Å Vegsundvåg, MD
Study Chair: Rune Wiseth, MD, PhD Norwegian University of Science and Technology
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00281346    
Other Study ID Numbers: 29 FU-71-05
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by Norwegian University of Science and Technology:
Doppler echocardiography
coronary stenosis
Coronary angiography
Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations