Clinical trial NCT00281346: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina Pectoris
Unstable Angina Pectoris
Acute Myocardial Infarction
Keywords: Doppler echocardiography
coronary stenosis
Coronary angiography
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic yield: Accuracy, positive and negative predictive value.
timeFrame: Inhospital
measure: pr patient evaluation
timeFrame: Inhospital
Secondary outcomes:
measure: pr stenosis evaluation
timeFrame: Inhospital
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Ålesund Hospital HF
Study officials:
affiliation: Norwegian University of Science and Technology
name: Torstein L Hole, MD, PhD
role: STUDY_CHAIR
name: Johnny Å Vegsundvåg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Rune Wiseth, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.