StrokeCRIMINCT02834143
Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2014to 14 Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ (Groupe Hospitalier Paris Saint Joseph) and having a life expectancy greater than one year.
Who may be able to join
- All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ and having a life expectancy greater than one year.
Who cannot join
- demented patient psychological condition
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not subject to a clear consensus.
Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European working group) in a population of severe ischemia in patients in order to offer relevant simple and reproducible criteria. Secondly Investigators propose to monitor the medium and long term evolution of these patients ICC defined to clarify the prognosis.
Read more
diagnostic criteria of the different societies:
- TASC: Transatlantic criteria: very characteristic pain, wound optional, variable hemodynamic criteria as the presence of a wound or not
- VALMI: French criteria derived vascular medical college: characteristic pain, sore, hemodynamic reproducible, reliable criteria
- European working group: European definition of criteria, including a characteristic pain, requires no wound, different hemodynamic criteria of 2 others.
Read the detailed description
Main objective / secondary:
- Main objective: Evaluation of diagnostic criteria for chronic critical limb ischemia
- Secondary objectives:
- Evaluation of the quality of life,
- Evaluation of the need for psychological counseling a patient at the stage of chronic critical limb ischemia,
- Evaluation of the interest of a specific bioassay
Development of the study:
The offer document and the non-opposition of the patient will be collected on the first day of hospitalization, quality of life questionnaires will also be distributed at the beginning of hospitalization.
Clinical data will be collected during hospitalization of the patient, respecting their anonymity, only the place of birth shall be retained in terms of data that distinguish patients.
During the consultation of control, a half months post-hospitalization, diagnostic criteria will be reviewed and the quality of life (using the same questionnaire) and the need or not for psychological help (oral question).
The doctor will be called between 3 and 6 months following hospitalization to assess her patient monitoring criteria, rhythm monitoring, the psychological impact of the disease on the patient seen by the physician, assessment loss of independence due to illness.
The number of hospitalizations for chronic critical ischemia of six months shall be obtained.
Methodology :
Design: Prospective, mono centric, non-interventional (observational) consecutive patients attending the service Vascular Medicine.
Study duration: 6 months: about 150 to 180 patients included in the study, about 50 have clinical chronic critical limb ischemia criteria.
- Conditions
- Stroke
- Being tested
- No intervention
- Keywords
- vascular, Limb Ischemia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The is no intervention. This study is a descriptive one
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Measured: Day 1, then Day 45 after hospitalization
Assessent of change of VALMI (French criteria derived vascular medical college)
French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable
Measured: Day 1, then Day 45 after hospitalization
Assessent of change of the European working group criteria
European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.
Measured: Day 1, then Day 45 after hospitalization
Secondary outcomes (3)
Assessent of quality of life
Quality of Life questionnaire validated by the French Society of Angiology (SF 12)
Measured: Day 1, then Day 45 after hospitalization
Evaluation of the need for psychological counseling
Evaluation of the need of the patient for psychological counseling at the stage of chronic critical limb ischemia: questions posed orally directly to the patient "do you feel the need for psychological counseling? "(When viewing control, a month and a half after hospitalization)
Possible answers are : yes or no
Measured: Day 1, then Day 45 after hospitalization
Evaluation of the interest of a specific bioassay
Evaluation of the interest of a specific bioassay: no additional assay carried out for the study, only biologies prescribed as part of its usual management will be carried out
Possible answers are : yes or no
Measured: Day 1, then Day 45 after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start13 Jun 2014
- Primary completion14 Jan 2015
- Study completion14 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michon Pasturel Ulrique, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834143
- Sponsor's protocol ID
- CRIMI
- Acronym
- CRIMI
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02834143
- Acronym / sponsor ID
- CRIMI / CRIMI
- Conditions
- Stroke
- Keywords
- vascular, Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 Jun 2014 (actual)
- Primary completion
- 14 Jan 2015 (actual)
- Study completion
- 14 Jun 2015 (actual)
- First posted
- 15 Jul 2016 (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.
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not subject to a clear consensus.
Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European working group) in a population of severe ischemia in patients in order to offer relevant simple and reproducible criteria. Secondly Investigators propose to monitor the medium and long term evolution of these patients ICC defined to clarify the prognosis.
diagnostic criteria of the different societies:
- TASC: Transatlantic criteria: very characteristic pain, wound optional, variable hemodynamic criteria as the presence of a wound or not
- VALMI: French criteria derived vascular medical college: characteristic pain, sore, hemodynamic reproducible, reliable criteria
- European working group: European definition of criteria, including a characteristic pain, requires no wound, different hemodynamic criteria of 2 others.
Detailed description
Main objective / secondary:
- Main objective: Evaluation of diagnostic criteria for chronic critical limb ischemia
- Secondary objectives:
- Evaluation of the quality of life,
- Evaluation of the need for psychological counseling a patient at the stage of chronic critical limb ischemia,
- Evaluation of the interest of a specific bioassay
Development of the study:
The offer document and the non-opposition of the patient will be collected on the first day of hospitalization, quality of life questionnaires will also be distributed at the beginning of hospitalization.
Clinical data will be collected during hospitalization of the patient, respecting their anonymity, only the place of birth shall be retained in terms of data that distinguish patients.
During the consultation of control, a half months post-hospitalization, diagnostic criteria will be reviewed and the quality of life (using the same questionnaire) and the need or not for psychological help (oral question).
The doctor will be called between 3 and 6 months following hospitalization to assess her patient monitoring criteria, rhythm monitoring, the psychological impact of the disease on the patient seen by the physician, assessment loss of independence due to illness.
The number of hospitalizations for chronic critical ischemia of six months shall be obtained.
Methodology :
Design: Prospective, mono centric, non-interventional (observational) consecutive patients attending the service Vascular Medicine.
Study duration: 6 months: about 150 to 180 patients included in the study, about 50 have clinical chronic critical limb ischemia criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ (Groupe Hospitalier Paris Saint Joseph) and having a life expectancy greater than one year.
Key inclusion criteria (1 listed)
- All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ and having a life expectancy greater than one year.
Key exclusion criteria (1 listed)
- demented patient psychological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThe is no intervention. This study is a descriptive one | Other | – |
Primary outcome
Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Time frame: Day 1, then Day 45 after hospitalization
Assessent of change of VALMI (French criteria derived vascular medical college)
Time frame: Day 1, then Day 45 after hospitalization
French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable
Assessent of change of the European working group criteria
Time frame: Day 1, then Day 45 after hospitalization
European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.
3 secondary outcomes
Assessent of quality of life
Time frame: Day 1, then Day 45 after hospitalization
Evaluation of the need for psychological counseling
Time frame: Day 1, then Day 45 after hospitalization
Evaluation of the interest of a specific bioassay
Time frame: Day 1, then Day 45 after hospitalization
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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Michon Pasturel Ulrique, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Stroke, run by Fondation Hôpital Saint-Joseph 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 1 inclusion and 1 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 23 Feb 2017. 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?
Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) (time frame: Day 1, then Day 45 after hospitalization). The study lists 3 primary outcomes in all. 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 23 Feb 2017.