Star-Close Early Ambulation Trial - Full Text View

Sponsor:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00590798

Purpose

To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

Condition	Intervention
Cardiovascular Disease	Behavioral: Walking

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Star-Close Early Ambulation Trial

Further study details as provided by Ohio State University:

Primary Outcome Measures:

Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization [ Time Frame: 7 days post procedure ] [ Designated as safety issue: Yes ]

Enrollment:	223
Study Start Date:	April 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.	Behavioral: Walking Patient will walk within 30 minutes of vascular closure system procedure
2: No Intervention Observation of patient after Star-Close vascular closure system.

Detailed Description:

To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients admitted to for an outpatient left heart catheterization
Catheterization through the femoral artery
Able to ambulate at least 20 feet
Able to receive the Star-Close Vascular Closure System
Be a candidate for hospital discharge following catheterization

Exclusion Criteria:

Known peripheral arterial disease
Blood pressure greater than 180/110
Pregnant or lactating
Anemic or low blood count
Blood thinning medication within 5 days before catheterization
Unable to walk 20 feet with out rest
Complications during catheterization procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590798

Locations

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

Earnest L Mazzaferri Jr, MD

The Ohio State University Medical Center, Division of Cardiovascular Medicine

More Information

No publications provided

Responsible Party:	The Ohio State University Division of Cardiovascular Medicine ( Ernest Mazzaferri, Jr. MD, Assistant Professor - Clinical )
Study ID Numbers:	STRUT
Study First Received:	December 26, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00590798 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Cardiac Catheterization
Walk
Heart Catheterization

Coronary Disease
Heart Disease
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 22, 2009