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Systolic Pressure Index in Assessing the Risk of Cardiovascular Events (IPS)

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ClinicalTrials.gov Identifier: NCT00925964
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
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.

Condition or disease
Cardio-vascular Events

Study Type : Observational
Estimated Enrollment : 504 participants
Time Perspective: Prospective
Official Title: Interest of Measuring the Systolic Pressure Index in Assessing the Risk of Cardiovascular Events Peri-operatively in the Surgery, Settled Out of Cardiovascular Surgery
Study Start Date : January 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Group/Cohort
Patients exposed
Patients with Systolic Pressure Index <0,9 ou >1,4.
Patients not exposed
Patients with Systolic Pressure Index >0,9 ou <1,4.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. - 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 ]

Biospecimen Retention:   Samples Without DNA
Blood sample to evaluate Troponin, a Cardiac biomarker


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925964


Locations
France
Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Philippe LACROIX, MD University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00925964     History of Changes
Other Study ID Numbers: I07029
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: June 2009