Cardiovascular DiseaseSTRUTNCT00590798
Star-Close Early Ambulation Trial
A study testing Walking in people with Cardiovascular Disease, run by Ernest Mazzaferri at 1 site in United States.
Trial summary
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Walking
- Keywords
- Cardiac Catheterization, Walk, Heart Catheterization, Coronary Disease, Heart Disease, Coronary Artery Disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
Patient will walk within 30 minutes of vascular closure system procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization
Measured: 7 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ernest Mazzaferri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ernest Mazzaferri, Ohio State University
- Investigators
- Earnest L Mazzaferri Jr, MD, Principal investigator, The Ohio State University Medical Center, Division of Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590798
- Sponsor's protocol ID
- STRUT
- Acronym
- STRUT
- Status last verified
- Apr 2013
- First submitted
- 26 Dec 2007
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Star-Close Early Ambulation Trial
- ClinicalTrials.gov ID
- NCT00590798
- Acronym / sponsor ID
- STRUT / STRUT
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiac Catheterization, Walk, Heart Catheterization, Coronary Disease, Heart Disease, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ernest MazzaferriUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: WalkingPatients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingPatient will walk within 30 minutes of vascular closure system procedure | Behavioural | 1 |
Primary outcome
Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization
Time frame: 7 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earnest L Mazzaferri Jr, MD principal investigator
The Ohio State University Medical Center, Division of Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Cardiovascular Disease, run by Ernest Mazzaferri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization (time frame: 7 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.