Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging - Tabular View

Tracking Information

First Received Date ^ICMJE

November 8, 2005

Last Updated Date

August 20, 2008

Start Date ^ICMJE

February 2003

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00251615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging

Official Title ^ICMJE

Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging

Brief Summary

The purpose of this study is to learn what changes in blood vessel contraction may occur as a result of a disease of the vessel that requires surgery. The study will examine the calcium channels present in the vessels being operated on, and the genes that may alter blood vessel function. Possible variation in these genes may change the kind of calcium channels present in blood vessels.

Detailed Description

The goal of this study is to learn more about how blood vessels function and the mechanism that causes them to contract. The study will investigate the natural history of diseased blood vessel tissue and the calcium channels in the muscle part of the blood vessel. The study will also examine how genetics influences cardiovascular disease and its causes and treatments.

Patients scheduled for vascular surgery will be approached to participate in this study. During surgery, tissue fragments of diseased and marginal tissue will be obtained. A blood sample will be obtained at either the time of surgery or consent and genomic DNA will be extracted.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Cross-Sectional

Condition ^ICMJE

Atherosclerosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ages 21 and older
Scheduled for vascular surgery

Exclusion Criteria:

Unwillingness to be subjected to diagnostic and/or therapeutic procedures that are deemed not necessary for clinical management
Volunteers deemed too fragile to participate in the study by the principal investigator (PI) or the attending physician
Inability to obtain informed consent from either the volunteer or the responsible party (durable power of attorney [DPA]) for the volunteer, with the volunteer's assent

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00251615

Responsible Party

Samer Najjar, MD, National Institute of Aging

Study ID Numbers ^ICMJE

AG0058

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Samer Najjar, MD

National Institute on Aging (NIA)

Information Provided By

National Institute on Aging (NIA)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP