Coronary Artery Study in Pediatric Heart Transplantation | NCT01546870

Studies
Coronary Artery Study in Pediatric Heart Transplantation

NCT01546870

Sponsor

Arkansas Children's Hospital Research Institute

Status

Withdrawn

Last Update Posted

Jun 20, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Transplant Coronary Artery Disease

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

never approved by IRB

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Mar 3, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 7, 2012Estimated

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

Jun 16, 2016

Last Update Posted Date

Jun 20, 2016Estimated

Name	Class
University of Arkansas	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

Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.

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

0Actual

Label	Type	Description	Intervention Names
pediatric heart transplant recipients

Measure	Description	Time Frame
Clinical coronary artery disease		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

less than 21 years and above 7 years of age

Exclusion Criteria:

clinically significant coronary artery disease on angiography and inability to undergo IVUS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Pediatric heart transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's hospital		Little Rock	Arkansas	72223	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16818118	Background	Fearon WF, Hirohata A, Nakamura M, Luikart H, Lee DP, Vagelos RH, Hunt SA, Valantine HA, Fitzgerald PJ, Yock PG, Yeung AC. Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic Investigation for Transplant Arteriopathy II (PITA II) study. J Heart Lung Transplant. 2006 Jul;25(7):765-71. doi: 10.1016/j.healun.2006.03.003. Epub 2006 May 24.