- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925964
Systolic Pressure Index in Assessing the Risk of Cardiovascular Events (IPS)
March 14, 2012 updated by: University Hospital, Limoges
Interest of Measuring the Systolic Pressure Index in Assessing the Risk of Cardiovascular Events Peri-operatively in the Surgery, Settled Out of Cardiovascular Surgery
To investigate whether the presence of a Systolic pressure index (<0.9
or> 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
504
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Limoges, France, 87000
- Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients from thoracic surgery, cardiovascular surgery and transplantation,urologic surgery, gastrointestinal surgery and orthopedic surgery services and coming to a preoperative anesthesia consultation are concerned with the study.
Description
Inclusion Criteria:
- age> 40 years
- surgery set :
- Visceral surgery: gastrectomy or colectomy, abdomino-perineal amputation, pancreatic surgery, liver surgery, esophageal surgery
- In urological surgery: nephrectomy, total prostatectomy, cystectomy
- In thoracic surgery: pneumonectomy, lobectomy
- In orthopedic surgery: total hip replacement and total knee prosthesis
Exclusion Criteria:
- pathology making it impossible to measure Systolic Pressure Index
- life expectancy less than 6 months
- emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients exposed
Patients with Systolic Pressure Index <0,9 ou >1,4.
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Patients not exposed
Patients with Systolic Pressure Index >0,9 ou <1,4.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
It is a composite involving the following events: death, cardiovascular death, acute coronary syndrome, left cardiac decompensation, stroke, transient ischemic attack
Time Frame: day1, day 2, day 3, 1 month, 1 year
|
day1, day 2, day 3, 1 month, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
- for the short term increase in the length of hospitalization - for the long term: death, cardiovascular death, hospitalization for acute coronary syndrome, cardiac decompensation left, TIA, stroke, acute ischemia and ischemia critical member.
Time Frame: day1, day 2, day 3, 1 month, 1 year
|
day1, day 2, day 3, 1 month, 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philippe LACROIX, MD, University Hospital, Limoges
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 22, 2009
First Posted (Estimate)
June 23, 2009
Study Record Updates
Last Update Posted (Estimate)
March 15, 2012
Last Update Submitted That Met QC Criteria
March 14, 2012
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I07029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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