Forearm Vascular Relaxation | NCT00182923

Studies
Forearm Vascular Relaxation

NCT00182923

Sponsor

National Institute on Aging (NIA)

Status

Completed

Last Update Posted

Aug 29, 2008Estimated

Enrollment

400

Phase

Not provided

Conditions

Healthy

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

Aug 2008

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

May 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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

Aug 28, 2008

Last Update Posted Date

Aug 29, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs

Detailed Description

Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.

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

400

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal physical status without any medical interventions or agents which would alter the defined status of normal

Exclusion Criteria:

Age less than 21 or greater than 45
Unable to give informed consent
BMI (Body Mass Index) less than 18 or greater than 25
Clinically significant abnormal laboratory values
Abnormal physical exam
Abnormal EKG
Pregnancy
Smoking or drug usage (illicit or otherwise)
Post-menopause
Participation in another clinical trial in the past month
Chronic Illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darrell R. Abernethy, MD, PhD	National Institute on Aging, Laboratory of Clinical Investigation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute on Aging (NIA), Harbor Hospital		Baltimore	Maryland	21225	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7554707	Background	Abernethy DR, Laurie N, Andrawis NS. Local angiotensin-converting enzyme inhibition blunts endothelin-1-induced increase in forearm vascular resistance. Clin Pharmacol Ther. 1995 Sep;58(3):328-34. doi: 10.1016/0009-9236(95)90250-3.
2162750	Background	Abernethy DR, Winterbottom LM. Forearm vascular alpha 1-adrenergic blockade by verapamil. Clin Pharmacol Ther. 1990 Jun;47(6):755-9. doi: 10.1038/clpt.1990.104.