Myocardial Perfusion Echocardiography to Detect Human Hea... | NCT02300870

Studies
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

NCT02300870

Sponsor

Brigham and Women's Hospital

Status

Terminated

Last Update Posted

Jul 27, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Heart Transplantation

Interventions

Optison

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Nov 17, 2014

First Submission Date that Met QC Criteria

Nov 21, 2014

First Posted Date

Nov 25, 2014Estimated

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

Jul 26, 2023

Last Update Posted Date

Jul 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Givertz, MD, Medical Director, Heart Transplant and Mechanical Circulatory Support, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
General Electric	INDUSTRY

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 primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.

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

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart Transplant Rejection		Patients presenting with acute cellular rejection	Drug: Optison
Heart Transplant Control		Patients presenting for routine office visit	Drug: Optison

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optison	Drug	Echocardiogram with IV contrast	Heart Transplant Control Heart Transplant Rejection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global and regional microvascular myocardial perfusion	Myocardial blood flow (dB/s)	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital

Exclusion Criteria:

hemodynamic instability (e.g., systolic blood pressure < 90 mmHg)
atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm)
premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
poor acoustic windows
inability to provide informed consent
any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Heart Transplant patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Givertz, MD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C099458	FS 069

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided