Non-invasive Diagnosis of Coronary Artery Stenoses by Dop... | NCT00281346

Studies
Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

NCT00281346

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 18, 2016Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Stable Angina Pectoris
Unstable Angina Pectoris
Acute Myocardial Infarction

Interventions

Doppler echocardiography

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jan 23, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2016

Last Update Posted Date

Jul 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transthoracic Doppler echocardiography	Experimental		Procedure: Doppler echocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler echocardiography	Procedure	Echocardiography	transthoracic Doppler echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic yield: Accuracy, positive and negative predictive value.		Inhospital
pr patient evaluation		Inhospital

Secondary Outcomes

Measure	Description	Time Frame
pr stenosis evaluation		Inhospital

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ålesund Hospital HF		Ålesund		N-6026	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26113119	Result	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.
24628779	Derived

ID	Term
D060050	Angina, Stable
D000789	Angina, Unstable
D023921	Coronary Stenosis

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases