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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00925964
First received: June 22, 2009
Last updated: March 14, 2012
Last verified: June 2009
  Purpose

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
Cardio-vascular Events

Study Type: Observational
Study Design: 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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood sample to evaluate Troponin, a Cardiac biomarker


Estimated Enrollment: 504
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00925964     History of Changes
Other Study ID Numbers: I07029
Study First Received: June 22, 2009
Last Updated: March 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on November 25, 2014