Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00281346
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Pectoris; Unstable Angina Pectoris; Acute Myocardial Infarction	Procedure: Doppler echocardiography	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transthoracic Doppler echocardiography	Procedure: Doppler echocardiography; Echocardiography

Outcome Measures

Primary Outcome Measures

1. Diagnostic yield: Accuracy, positive and negative predictive value. [Inhospital]

2. pr patient evaluation [Inhospital]

Secondary Outcome Measures

1. pr stenosis evaluation [Inhospital]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00281346
• Other Study ID Numbers: 29 FU-71-05
• First Posted: Jan 24, 2006
• Last Update Posted: Jul 18, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Norwegian University of Science and Technology: Doppler echocardiography; coronary stenosis; Coronary angiography
• Additional relevant MeSH terms: Myocardial Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Infarction

Study Results

No Results Posted as of Jul 18, 2016