Non-Invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography - Full Text View

Purpose

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	Intervention
Stable Angina Pectoris Unstable Angina Pectoris Acute Myocardial Infarction	Procedure: Doppler echocardiography

MedlinePlus related topics:

Angina Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Non-Invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Diagnostic yield: Accuracy, positive and negative predictive value. [ Time Frame: Inhospital ] [ Designated as safety issue: No ]
pr patient evaluation [ Time Frame: Inhospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pr stenosis evaluation [ Time Frame: Inhospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2007
Estimated Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Echocardiography

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281346

Locations


Norway
	Ålesund Hospital HF
	Ålesund, Norway, N-6026

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators


Study Chair:	Torstein L Hole, MD, PhD	Norwegian University of Science and Technology

Principal Investigator:	Johnny Å Vegsundvåg, MD	Unaffiliated

Study Chair:	Rune Wiseth, MD, PhD	Norwegian University of Science and Technology

More Information

Publications:

Hozumi T, Yoshida K, Ogata Y, Akasaka T, Asami Y, Takagi T, Morioka S. Noninvasive assessment of significant left anterior descending coronary artery stenosis by coronary flow velocity reserve with transthoracic color Doppler echocardiography. Circulation. 1998 Apr 28;97(16):1557-62.

Matsumura Y, Hozumi T, Watanabe H, Fujimoto K, Sugioka K, Takemoto Y, Shimada K, Muro T, Yoshiyama M, Takeuchi K, Yoshikawa J. Cut-off value of coronary flow velocity reserve by transthoracic Doppler echocardiography for diagnosis of significant left anterior descending artery stenosis in patients with coronary risk factors. Am J Cardiol. 2003 Dec 15;92(12):1389-93.

Lethen H, P Tries H, Kersting S, Lambertz H. Validation of noninvasive assessment of coronary flow velocity reserve in the right coronary artery. A comparison of transthoracic echocardiographic results with intracoronary Doppler flow wire measurements. Eur Heart J. 2003 Sep;24(17):1567-75.

Responsible Party:	Norwegian University of Science and Technology ( Torstein Hole )
Study ID Numbers:	29 FU-71-05
First Received:	January 23, 2006
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00281346
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Doppler echocardiography

coronary stenosis

Coronary angiography

Study placed in the following topic categories:

Heart Diseases

Myocardial Ischemia

Angina Pectoris

Vascular Diseases

Constriction, Pathologic

Pain

Ischemia

Coronary Stenosis

Chest Pain

Coronary Disease

Signs and Symptoms

Necrosis

Infarction

Myocardial Infarction

Angina, Unstable

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00281346