Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

Acute Myocardial Infarction Clinical Trial

Official title:

Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281346
• Other study ID #: 29 FU-71-05
• Status: Completed
• Phase: N/A
• First received: January 23, 2006
• Last updated: July 15, 2016
• Start date: December 2005
• Est. completion date: August 2008

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Stable Angina Pectoris
• Unstable Angina Pectoris

Intervention

Procedure:
• Doppler echocardiography
Echocardiography

Locations

Country	Name	City	State
Norway	Ålesund Hospital HF	Ålesund

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Holte E, Vegsundvåg 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield: Accuracy, positive and negative predictive value.		Inhospital	No
Primary	pr patient evaluation		Inhospital	No
Secondary	pr stenosis evaluation		Inhospital	No