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

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

      • Limoges, France, 87000
        • Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)

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
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.

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.

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.

Clinical Trials on Cardio-vascular Events

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