Non-Invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

This study has been completed.
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00281346
First received: January 23, 2006
Last updated: January 9, 2009
Last verified: January 2009
  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:


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:
    Procedure: Doppler echocardiography
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014