NCT00925964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 15, 2012

Status Verified

June 1, 2009

Enrollment Period

1.6 years

First QC Date

June 22, 2009

Last Update Submit

March 14, 2012

Conditions

Cardio-vascular Events

Outcome Measures

Primary Outcomes (1)

  • It is a composite involving the following events: death, cardiovascular death, acute coronary syndrome, left cardiac decompensation, stroke, transient ischemic attack

    day1, day 2, day 3, 1 month, 1 year

Secondary Outcomes (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.

    day1, day 2, day 3, 1 month, 1 year

Study Arms (2)

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 Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • pathology making it impossible to measure Systolic Pressure Index
  • life expectancy less than 6 months
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)

Limoges, 87000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample to evaluate Troponin, a Cardiac biomarker

Study Officials

  • Philippe LACROIX, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

March 15, 2012

Record last verified: 2009-06

Locations

FR(1)