Diagnosis and Characterization of Coronary Artery Stenosi... | NCT00521326

Studies
Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound

NCT00521326

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Aug 27, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Coronary Stenosis

Interventions

Not provided

Countries

Israel

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

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 24, 2007

First Submission Date that Met QC Criteria

Aug 24, 2007

First Posted Date

Aug 27, 2007Estimated

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

Aug 24, 2007

Last Update Posted Date

Aug 27, 2007Estimated

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

The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.

Detailed Description

Not provided

Conditions Module

Conditions

Coronary Stenosis

Keywords

doppler
coronary stenosis
non-invasive testing
A prospective study of a new diagnostic method.
Study consists of a transthoracic doppler of LAD.
Doppler to be performed prior to coronary angiography.
F/U doppler examination for those who undergo PCI.
Doppler results will be compared with coronary angiography.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Patients with an acute coronary syndrome that are candidates for coronary angiography. Doppler results will be compared to angiographic findings.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are clinically suspected of having significant coronary artery stenosis.
Patients with CAD.
Patients who are scheduled to undergo coronary angiography.
Signed informed consent.

Exclusion Criteria:

Patients with arrhythmia / irregular pulse
Patients with unstable conditions: unstable angina, uncontrolled CHF
Patients with COPD
Any physical or medical disability that prevent lying in supine position
Patients with chest wall deformity

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simcha R Meisel, MD, MSc	Contact	972-4-630-4656		meisel@hy.health.gov.il
Avraham Shotan, MD	Contact	972-4-630-4428		shotana@yahoo.com

Overall Officials

Name	Affiliation	Role
Simcha R Meisel, MD, MSc	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coronary Care Unit, Heart Institute, Hille Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided