Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

NCT ID: NCT00281346

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stable Angina Pectoris Unstable Angina Pectoris Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transthoracic Doppler echocardiography

Group Type EXPERIMENTAL

Doppler echocardiography

Intervention Type PROCEDURE

Echocardiography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doppler echocardiography

Echocardiography

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Torstein L Hole, MD, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Johnny Å Vegsundvåg, MD

Role: PRINCIPAL_INVESTIGATOR

Rune Wiseth, MD, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ålesund Hospital HF

Ålesund, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26113119 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24628779 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21524564 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20028530 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29 FU-71-05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.