IschemiaSARTORIUSNCT02834351
Tissue Lesions in Exercise Related Ischemia
A study testing Muscle Biopsy in people with Ischemia and Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function. Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Peripheral Artery Disease
- What is being tested?
- Muscle Biopsy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Nov 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intervention for femoropopliteal bypass (PAD group)
- Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)
Who cannot join
- Participate in another biomedical research
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain
The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.
Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.
Read the detailed description
Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.
Analysis of the activity of mitochondrial chain Immunochemistry of tissue markers
- Conditions
- Ischemia, Peripheral Artery Disease
- Being tested
- Muscle Biopsy
- Medical subject headings
- Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle BiopsyOther
A distal and proximal biopsy of the sartorius muscles ( 0.5 cm3 each) will be performed during surgery for saphenous vein withdrawal (cardiac group) or arterial bypass (PAD group) The samples are then treated with neurovascular and mitochondrial biology laboratory.
the activity of the complex 1 is analyzed and compared between the 2 groups.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral artery diseased group | Active comparator | pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery Receives: Other: Muscle Biopsy |
| Cardiac group | Sham comparator | Patients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery Receives: Other: Muscle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.
Measurement of mitochondrial complex 1 activity (arbitrary units) on muscle biopsies by the laboratory of biochemistry. Comparison of the results observed on the same miuscle at the proximal level (assumed normal in both groups) and distal level (assumed ischemic in claudicants but not in cardiac patients without limb symptoms.
Measured: 1 week
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 startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, PROFESSOR, Principal investigator, UH ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834351
- Sponsor's protocol ID
- 2013-A00166-39
- Acronym
- SARTORIUS
- Status last verified
- Dec 2016
- First submitted
- 16 Jun 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain
- ClinicalTrials.gov ID
- NCT02834351
- Acronym / sponsor ID
- SARTORIUS / 2013-A00166-39
- Conditions
- Ischemia, Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (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.
The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.
Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.
Detailed description
Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.
Analysis of the activity of mitochondrial chain Immunochemistry of tissue markers
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral artery diseased group | Active comparator | Other: Muscle Biopsypad Patients referred for femoro popliteal bypass Muscle biopsy during surgery |
| Cardiac group | Sham comparator | Other: Muscle BiopsyPatients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intervention for femoropopliteal bypass (PAD group)
- Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)
Key exclusion criteria (2 listed)
- Participate in another biomedical research
- Pregnant woman
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 |
|---|---|---|
| Muscle BiopsyA distal and proximal biopsy of the sartorius muscles ( 0.5 cm3 each) will be performed during surgery for saphenous vein withdrawal (cardiac group) or arterial bypass (PAD group) The samples are then treated with neurovascular and mitochondrial biology laboratory. the activity of the complex 1 is analyzed and compared between the 2 groups. | Other | Cardiac group, Peripheral artery diseased group |
Primary outcome
Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.
Time frame: 1 week
Measurement of mitochondrial complex 1 activity (arbitrary units) on muscle biopsies by the laboratory of biochemistry. Comparison of the results observed on the same miuscle at the proximal level (assumed normal in both groups) and distal level (assumed ischemic in claudicants but not in cardiac patients without limb symptoms.
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 19 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Ischemia
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
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.
Pierre ABRAHAM, PROFESSOR principal investigator
UH ANGERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Biopsy in people with Ischemia and Peripheral Artery Disease, run by University Hospital, Angers 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 2 inclusion and 2 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 19 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2. (time frame: 1 week). 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 19 Dec 2016.