Ventricular Remodeling In Patients With Aortic Stenosis A... | NCT00774657

Studies
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography

NCT00774657

Sponsor

Lahey Clinic

Status

Withdrawn

Last Update Posted

Feb 17, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Not provided

Countries

United States

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to identify and recruit suitable study subjects

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Oct 16, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 2008Estimated

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

Feb 16, 2012

Last Update Posted Date

Feb 17, 2012Estimated

Name	Class
Tufts Medical Center	OTHER

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

This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis

Detailed Description

This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.

Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.

Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Assess doppler diastolic filling indices for patterns of LV remodeling		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects more than 18 yrs of age through 90 yrs of age
Both male and female
Patients with moderate or severe isolated Aortic Stenosis
Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.

Exclusion Criteria:

Poor acoustic windows
h/o CAD and wall motion abnormality

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

Lahey Clinic patients who have been referred to the echocardiography lab for clinical indications, found to have a aortic stenosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sherif B. Labib, M.D.	Lahey Clinic, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahey Clinic, Inc.		Burlington	Massachusetts	01805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7985830	Background	Faggiano P, Rusconi C, Ghizzoni G, Sabatini T. Left ventricular remodeling and function in adult aortic stenosis. Angiology. 1994 Dec;45(12):1033-8. doi: 10.1177/000331979404501206.
15860517	Background	Kupari M, Turto H, Lommi J. Left ventricular hypertrophy in aortic valve stenosis: preventive or promotive of systolic dysfunction and heart failure? Eur Heart J. 2005 Sep;26(17):1790-6. doi: 10.1093/eurheartj/ehi290. Epub 2005 Apr 28.

ID	Term
D001024	Aortic Valve Stenosis
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D000082862	Aortic Valve Disease
D014694	Ventricular Outflow Obstruction