Systolic Pressure Index in Assessing the Risk of Cardiova... | NCT00925964

Studies
Systolic Pressure Index in Assessing the Risk of Cardiovascular Events

NCT00925964

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Mar 15, 2012Estimated

Enrollment

504Estimated

Phase

Not provided

Conditions

Cardio-vascular Events

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jun 22, 2009

First Submission Date that Met QC Criteria

Jun 22, 2009

First Posted Date

Jun 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

504Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	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.		day1, day 2, day 3, 1 month, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe LACROIX, MD	University Hospital, Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)		Limoges		87000	France