Study of Echocardiogram Accuracy in Patients With Mitral... | NCT01442467

Studies
Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

NCT01442467

Sponsor

Creighton University

Status

Terminated

Last Update Posted

Apr 1, 2013Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

Mitral Annulus Calcification

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subject accrual too difficult

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Aug 8, 2011

First Submission Date that Met QC Criteria

Sep 27, 2011

First Posted Date

Sep 28, 2011Estimated

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

Mar 28, 2013

Last Update Posted Date

Apr 1, 2013Estimated

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 study aims to evaluate the accuracy of the echocardiographic data obtained from patients with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.

Echocardiography is a non-invasive (does not break the skin) procedure used to see an image of the heart. It uses harmless sound waves to create an image of the heart on a computer screen. These images will show the valves of the heart, how well the heart is pumping blood, the blood flow across these valves and how large the heart is. A silver paddle-shaped device is moved easily over the skin to capture these images.

Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the valves) is a common finding and it increases with age. The presence of calcification changes the blood flow through the heart valves. This makes any echocardiographic data (information) obtained from patients with calcifications difficult to interpret.

Detailed Description

Patients with significant mitral annular calcification (MAC) have largely been excluded from studies validating non invasive (echocardiographic) measurements of left ventricular filling and diastolic function. The investigators hypothesize that echocardiographic estimates of diastolic function, left atrial pressure (LAP) and left ventricular end diastolic pressure (LVEDP) are likely to be fallacious in patients with moderate to severe mitral annular calcification due to the structural alterations and technical difficulties involved.

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

4Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agreement between invasive and non-invasive measures of LVEDP	evaluate the agreement between the E/E' ratio by echocardiography and the left ventricular end-diastolic pressure by cardiac catheterization in patients with moderate to severe mitral annular calcification	participants will be followed for the duration of hospital stay, an expected average of 2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>= 19 years of age
undergoing planned cardiac catheterization

Exclusion Criteria:

< 19 years of age
acute coronary syndrome
decompensated heart failure
not in sinus rhythm
> mild MR
hypertensive urgency/emergency
severe aortic stenosis
poor echo windows for Doppler imaging

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

elective/planned cardiac catheterization

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton Unviversity Medical Center		Omaha	Nebraska	68131	United States

Label	Type	Description	Intervention Names
Mild to Severe MAC
No to mild MAC