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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Non-Invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack

U.S. FDA Resources

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 ]

Enrollment:	110
Study Start Date:	December 2005
Study Completion Date:	August 2008
Primary Completion Date:	January 2008 (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
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vegsundvåg 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. Epub 2011 Apr 23.

Vegsundvåg 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.

Responsible Party:	Torstein Hole, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00281346 History of Changes
Other Study ID Numbers:	29 FU-71-05
Study First Received:	January 23, 2006
Last Updated:	January 9, 2009
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Doppler echocardiography
coronary stenosis
Coronary angiography

Additional relevant MeSH terms:

Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Coronary Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Coronary Disease

ClinicalTrials.gov processed this record on February 12, 2012