NCT00281346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

January 23, 2006

Last Update Submit

July 15, 2016

Conditions

Keywords

Doppler echocardiographycoronary stenosisCoronary angiography

Outcome Measures

Primary Outcomes (2)

  • Diagnostic yield: Accuracy, positive and negative predictive value.

    Inhospital

  • pr patient evaluation

    Inhospital

Secondary Outcomes (1)

  • pr stenosis evaluation

    Inhospital

Study Arms (1)

transthoracic Doppler echocardiography

EXPERIMENTAL
Procedure: Doppler echocardiography

Interventions

Echocardiography

transthoracic Doppler echocardiography

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unstable angina or acute myocardial infarction, or stable angina pectoris and
  • scheduled for coronary angiography on accepted clinical reasons

You may not qualify if:

  • past coronary artery grafting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ålesund Hospital HF

Ålesund, N-6026, Norway

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Angina, StableAngina, UnstableCoronary Stenosis

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary Disease

Study Officials

  • Torstein L Hole, MD, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR
  • Johnny Å Vegsundvåg, MD

    PRINCIPAL INVESTIGATOR
  • Rune Wiseth, MD, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

December 1, 2005

Primary Completion

January 1, 2008

Study Completion

August 1, 2008

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations