Cardio-vascular EventsIPSNCT00925964
Systolic Pressure Index in Assessing the Risk of Cardiovascular Events
An observational study of Cardio-vascular Events, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardio-vascular Events
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- pathology making it impossible to measure Systolic Pressure Index
- life expectancy less than 6 months
- emergency surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
Limoges, 87000
About this study
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
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.
- Conditions
- Cardio-vascular Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
It is a composite involving the following events: death, cardiovascular death, acute coronary syndrome, left cardiac decompensation, stroke, transient ischemic attack
Measured: 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.
Measured: day1, day 2, day 3, 1 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-vascular EventsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe LACROIX, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925964
- Sponsor's protocol ID
- I07029
- Acronym
- IPS
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00925964
- Acronym / sponsor ID
- IPS / I07029
- Conditions
- Cardio-vascular Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- pathology making it impossible to measure Systolic Pressure Index
- life expectancy less than 6 months
- emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe LACROIX, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-vascular Events, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.