Right Ventricular Hypertrophy and Pulmonary Hypertension:... | NCT00875940

Studies
Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis

NCT00875940

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Apr 6, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Diagnostic imaging procedures.

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

Apr 2009

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

Feb 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Not provided

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 6, 2009Estimated

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

Apr 3, 2009

Last Update Posted Date

Apr 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study hypothesis is that a quantitative index can be derived from Tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. Echocardiography provides the reference standard.

Detailed Description

Not provided

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
Group 1		Patients having both Tc-99m perfusion scan and echocardiogram.	Other: Diagnostic imaging procedures.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic imaging procedures.	Other		Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of quantitation of Tc-99m perfusion scans for identification of pulmonary hypertension.		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have an interpretable Tc-99m myocardial perfusion scan and an interpretable echocardiogram.

Exclusion Criteria:

Technically inadequate noninvasive test.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital population having diagnostic testing.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati		Cincinnati	Ohio	45267	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided