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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.
 
ClinicalTrials.gov Identifier: NCT00281346
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE January 23, 2006
First Posted Date  ICMJE January 24, 2006
Last Update Posted Date July 18, 2016
Study Start Date  ICMJE December 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
  • Diagnostic yield: Accuracy, positive and negative predictive value. [ Time Frame: Inhospital ]
  • pr patient evaluation [ Time Frame: Inhospital ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
  • Diagnostic yield: Accuracy, positive and negative predictive value.
  • pr patien evaluation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
pr stenosis evaluation [ Time Frame: Inhospital ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
pr stenosis evaluation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography
Official Title  ICMJE Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stable Angina Pectoris
  • Unstable Angina Pectoris
  • Acute Myocardial Infarction
Intervention  ICMJE Procedure: Doppler echocardiography
Echocardiography
Study Arms  ICMJE Experimental: transthoracic Doppler echocardiography
Intervention: Procedure: Doppler echocardiography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2009)
110
Original Enrollment  ICMJE
 (submitted: January 23, 2006)
100
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00281346
Other Study ID Numbers  ICMJE 29 FU-71-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Norwegian University of Science and Technology
Verification Date July 2016

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