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Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

Primary Purpose

Stable Angina Pectoris, Unstable Angina Pectoris, Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Doppler echocardiography
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stable Angina Pectoris focused on measuring Doppler echocardiography, coronary stenosis, Coronary angiography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ålesund Hospital HF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transthoracic Doppler echocardiography

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic yield: Accuracy, positive and negative predictive value.
pr patient evaluation

Secondary Outcome Measures

pr stenosis evaluation

Full Information

First Posted
January 23, 2006
Last Updated
July 15, 2016
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00281346
Brief Title
Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography
Official Title
Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Unstable Angina Pectoris, Acute Myocardial Infarction
Keywords
Doppler echocardiography, coronary stenosis, Coronary angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transthoracic Doppler echocardiography
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Doppler echocardiography
Intervention Description
Echocardiography
Primary Outcome Measure Information:
Title
Diagnostic yield: Accuracy, positive and negative predictive value.
Time Frame
Inhospital
Title
pr patient evaluation
Time Frame
Inhospital
Secondary Outcome Measure Information:
Title
pr stenosis evaluation
Time Frame
Inhospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torstein L Hole, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johnny Å Vegsundvåg, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Ålesund Hospital HF
City
Ålesund
ZIP/Postal Code
N-6026
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26113119
Citation
Holte E, Vegsundvag J, Hegbom K, Hole T, Wiseth R. Transthoracic Doppler for detection of stenoses in the three main coronary arteries by use of stenotic to prestenotic velocity ratio and aliased coronary flow. Eur Heart J Cardiovasc Imaging. 2015 Dec;16(12):1323-30. doi: 10.1093/ehjci/jev158. Epub 2015 Jun 25.
Results Reference
result
PubMed Identifier
24628779
Citation
Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary artery occlusions diagnosed by transthoracic Doppler. Cardiovasc Ultrasound. 2014 Mar 15;12:12. doi: 10.1186/1476-7120-12-12.
Results Reference
derived
PubMed Identifier
21524564
Citation
Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary flow velocity reserve in the three main coronary arteries assessed with transthoracic Doppler: a comparative study with quantitative coronary angiography. J Am Soc Echocardiogr. 2011 Jul;24(7):758-67. doi: 10.1016/j.echo.2011.03.010. Epub 2011 Apr 23.
Results Reference
derived
PubMed Identifier
20028530
Citation
Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Transthoracic echocardiography for imaging of the different coronary artery segments: a feasibility study. Cardiovasc Ultrasound. 2009 Dec 22;7:58. doi: 10.1186/1476-7120-7-58.
Results Reference
derived

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Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

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