Peripheral Vascular DiseaseNCT00378040
Systematic Assessment of Vascular Risk
An observational study of Peripheral Vascular Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population. The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2004to Dec 2015
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those with confirmend PAD
Who may be able to join
- All patients who attend the Vascular Surgery Clinic at Toronto General Hospital, St. Michael's Hospital, and St. Joseph's Health Centre who have PAD, cerebrovascular disease (CBVD), or aneurysms will be eligible for this study. Patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Toronto Vascular Disease Risk Factor Assessment Program: Systematic Assessment of Vascular Risk
It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population.
The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.
- Conditions
- Peripheral Vascular Disease
- Medical subject headings
- Peripheral Vascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lindsay, University Health Network, Toronto
- Investigators
- Thomas Lindsay, M.D, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378040
- Sponsor's protocol ID
- 01-541S
- Status last verified
- May 2016
- First submitted
- 15 Sep 2006
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: See JAMA Surgery 2016 epublished First Author Dr M Hussain
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toronto Vascular Disease Risk Factor Assessment Program: Systematic Assessment of Vascular Risk
- ClinicalTrials.gov ID
- NCT00378040
- Acronym / sponsor ID
- 01-541S
- Conditions
- Peripheral Vascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Sep 2006 (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.
It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population.
The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those with confirmend PAD
Key inclusion criteria (1 listed)
- All patients who attend the Vascular Surgery Clinic at Toronto General Hospital, St. Michael's Hospital, and St. Joseph's Health Centre who have PAD, cerebrovascular disease (CBVD), or aneurysms will be eligible for this study. Patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 May 2016.
- Individual participant dataSharing planned: Yes. See JAMA Surgery 2016 epublished First Author Dr M Hussain
Related trials for Peripheral Vascular Disease
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The THOR IDE Study
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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.
Thomas Lindsay, M.D principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 0 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 16 May 2016. 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 Canada. 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.
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 16 May 2016.