Intracoronary Bradykinin Mediated t-PA Release in Heart T... | NCT00780377

Studies
Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

NCT00780377

Sponsor

Vanderbilt University

Status

Withdrawn

Last Update Posted

Mar 20, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Heart Transplantation

Interventions

Bradykinin

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 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to perform study due to unavailable drug, then unable to partner with cath lab

Expanded Access Info

Start Date

Oct 2008Actual

Primary Completion Date

Jan 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 24, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

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 16, 2017

Last Update Posted Date

Mar 20, 2017Actual

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

Heart transplant recipients do not have nerves to their hearts. This protocol tests the hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in heart transplant recipients compared to healthy subjects.

This study will compare heart transplant recipients to healthy controls who are undergoing cardiac cath for standard of care purposes (separate protocol) and compare the coronary arteries to the forearm in transplant recipients (separate protocol) and healthy controls (separate protocol).

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bradykinin	Experimental	Patients have holter monitoring. Patients receive intracoronary bradykinin (0.2, 0.6, 2.0 ug/min) and have coronary sinus and coronary artery blood sampling for t-PA and O2 content.	Drug: Bradykinin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bradykinin	Drug	Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.	Bradykinin

Measure	Description	Time Frame
T-PA release in the coronary artery bed.		Single Study Visit

Measure	Description	Time Frame
Heart rate variability		Single study visit
Histopathology for arteriolar t-PA and sympathetic neurons		Single Study Visit

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Heart transplant recipients undergoing annual cardiac catheterization who have participated our protocol: Characterization of brachial arterial t-PA release, vasodilator function, and vascular compliance and correlation with fibrinolytic balance, oxidative stress, and inflammation measures in heart transplant recipients (SCCOR Project 1, Aim 3C). (IRB # 070517)
25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
Otherwise healthy

Exclusion criteria:

PVC < 30
Hypertensive subjects on ACE inhibitors
Pregnant or nursing mothers
Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
Triglycerides > 200
Previously diagnosed obstructive coronary artery disease
Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
History of cerebrovascular disease
Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
Angiotensin converting enzyme inhibitor use
Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
Peripheral Vascular Disease
Other chronic medical illnesses at the discretion of the investigators

Healthy controls are being enrolled in SCCOR Project 1, Aims 3A and 3B (IRB# 030473 and 061160) and will not be participating under this IRB number.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007705	Kinins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins