NCT02555527

Brief Summary

To perform a cost-effectiveness analysis for the routine use of contrast in rest echocardiography in patients with dilated or ischemic cardiomyopathy from the United States healthcare system, provider and payer perspectives.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

September 18, 2015

Last Update Submit

May 3, 2017

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dilated or ischemic cardiomyopathy and an ejection fraction (EF) ≤35% referred for clinically indicated, resting transthoracic echocardiography.

You may qualify if:

  • EF within last 3 months of \<=35%

You may not qualify if:

  • \<6 months life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pamela S Douglas, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

May 4, 2017

Record last verified: 2016-09

Locations

US(1)