Arterial Occlusive DiseasesSPECTROAOMINCT03723473
Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
An observational study of Arterial Occlusive Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
To explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2019to Apr 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Peripheral arterial occlusive disease with claudication and surgery planning
Who may be able to join
- Peripheral arterial occlusive disease (PAOD) with claudication and surgery planning with proximal lesion (iliac or femoral (x-ray angiography or CT or MRA) and no distal lesions (doppler)
- ABI<0.90 or >1.30
- signed consent form
- health insurance coverage
Who cannot join
- Contraindication in the practice of MRI: pacemaker, metallic cardiac valve, intra-ocular metal part, claustrophobia
- critical ischemia >15 days
- Type 1 or 2 diabetes
- weight >200kg
- non stabilized hypertension
- beta-blockers
- non-atherosclerotic vascular occlusive disease (Buerger disease, Takayasu disease, venous disease, trapped popliteal artery etc..)
- Neurological pathology/non-voluntary contraction
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Saint-Etienne
Saint-Etienne
Pierre CROISILLE, PhD
Jean-Noël ALBERTINI, PhD
About this study
Official title: Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
To explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease.
Read the detailed description
Peripheral arterial occlusive disease (PAOD) is defined as the partial or total obstruction of one or more lower extremity arteries, most often of atherosclerotic origin. It is a common disease whose 5-years mortality is near 30%.The positive diagnosis is based on clinical examination and measurement of the ankle-brachial index (ABI), which is the ratio of systolic pressure of ankle and brachial systolic pressure. The threshold value for the diagnosis is <0.90. Physiopathologically, mitochondria have the predominant role of providing the ATP necessary for the energetic needs of myocytes, which increase drastically during muscle contraction during exercise. This energy production is of course conditioned by the availability of oxygen. In patients with PAOD, the decrease in blood flow secondary to significant stenosis has the direct consequence of disrupting oxygen delivery to distal muscles and thus limiting muscular performance. Because mitochondrial respiration is the only metabolic pathway capable of providing the energy needed to sustain an effort of several minutes, intermittent claudication in PAOD has logically been related to a hemodynamic mechanism of intermittent muscle hypoperfusion. Recently, an increasing number of histological or functional studies have suggested that episodes of ischemia-reperfusion could induce mitochondrial dysfunction. Medical treatment of patients frequently includes statins while a direct deleterious effect on mitochondrial function has been suspected, inducing a deterioration of the muscular oxidative capacity which would increase the factors hemodynamics and may accumulate in mitochondrial myopathy. In the light of these elements, it is clear that there would be a benefit in being able to distinguish and quantify 1) the part of the reduction of mitochondrial activity secondary to the hemodynamic factor alone due to a decreased muscle perfusion 2) the mitochondrial involvement (mitochondriopathy) potentially induced by oxidative stress in PAOD. 2 sub-groups are distinguished to identify the statin-induced mitochondrial dysfunction.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Peripheral Arterial Occlusive Disease (PAOD), Phosphorus-31, Magnetic Resonance Imaging (MRI), Spectroscopy, Revascularization, Claudication with surgical planning
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Device
MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.
| Study group | Role | What they receive |
|---|---|---|
| PAOD patients statin (+) | Patients with Peripheral Arterial Occlusive Disease (PAOD) and statin treatment.
They will have Magnetic Resonance Imaging (MRI; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week) Receives: Device: Magnetic Resonance Imaging (MRI) | |
| PAOD patients statin (-) | Patients with Peripheral Arterial Occlusive Disease (PAOD) without statin treatment .
They will have Magnetic Resonance Imaging (MRI ; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week) Receives: Device: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle phosphocreatine (PCr) recovery time constant
Muscle phosphocreatine (PCr) recovery time constant (index of muscle aerobic capacity) after gated low-intensity exercise (2"maximum voluntary isometric dorsiflexion contractions, at 30s intervals for 8min (total contractions = 15)
Measured: During the MRI procedure
Secondary outcomes (2)
Muscular volume and content
impact of muscular volume and content. Measures will be extracted from DIXON and T2* MRI
Measured: During the MRI procedure
PCr recovery time constant
impact of statin treatment on PCr recovery time constant
Measured: During the MRI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start13 Feb 2019
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr MAYER Ronald A. Department of Physiology, Michigan State University, Dr SLADE Jill M. Department of Osteopathic Manipulative Medicine, Michigan State University
- Responsible party
- Sponsor
- Investigators
- Pierre CROISILLE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723473
- Sponsor's protocol ID
- 1708029
- Other IDs
- 2017-A01421-52
- Acronym
- SPECTROAOMI
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
- ClinicalTrials.gov ID
- NCT03723473
- Acronym / sponsor ID
- SPECTROAOMI / 1708029
- Conditions
- Arterial Occlusive Diseases
- Keywords
- Peripheral Arterial Occlusive Disease (PAOD), Phosphorus-31, Magnetic Resonance Imaging (MRI), Spectroscopy, Revascularization, Claudication with surgical planning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Dr MAYER Ronald A. Department of Physiology, Michigan State University, Dr SLADE Jill M. Department of Osteopathic Manipulative Medicine, Michigan State University
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 29 Oct 2018 (actual)
- 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 explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease.
Detailed description
Peripheral arterial occlusive disease (PAOD) is defined as the partial or total obstruction of one or more lower extremity arteries, most often of atherosclerotic origin. It is a common disease whose 5-years mortality is near 30%.The positive diagnosis is based on clinical examination and measurement of the ankle-brachial index (ABI), which is the ratio of systolic pressure of ankle and brachial systolic pressure. The threshold value for the diagnosis is <0.90. Physiopathologically, mitochondria have the predominant role of providing the ATP necessary for the energetic needs of myocytes, which increase drastically during muscle contraction during exercise. This energy production is of course conditioned by the availability of oxygen. In patients with PAOD, the decrease in blood flow secondary to significant stenosis has the direct consequence of disrupting oxygen delivery to distal muscles and thus limiting muscular performance. Because mitochondrial respiration is the only metabolic pathway capable of providing the energy needed to sustain an effort of several minutes, intermittent claudication in PAOD has logically been related to a hemodynamic mechanism of intermittent muscle hypoperfusion. Recently, an increasing number of histological or functional studies have suggested that episodes of ischemia-reperfusion could induce mitochondrial dysfunction. Medical treatment of patients frequently includes statins while a direct deleterious effect on mitochondrial function has been suspected, inducing a deterioration of the muscular oxidative capacity which would increase the factors hemodynamics and may accumulate in mitochondrial myopathy. In the light of these elements, it is clear that there would be a benefit in being able to distinguish and quantify 1) the part of the reduction of mitochondrial activity secondary to the hemodynamic factor alone due to a decreased muscle perfusion 2) the mitochondrial involvement (mitochondriopathy) potentially induced by oxidative stress in PAOD. 2 sub-groups are distinguished to identify the statin-induced mitochondrial dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAOD patients statin (+) | – | Device: Magnetic Resonance Imaging (MRI)Patients with Peripheral Arterial Occlusive Disease (PAOD) and statin treatment. They will have Magnetic Resonance Imaging (MRI; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week) |
| PAOD patients statin (-) | – | Device: Magnetic Resonance Imaging (MRI)Patients with Peripheral Arterial Occlusive Disease (PAOD) without statin treatment . They will have Magnetic Resonance Imaging (MRI ; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Peripheral arterial occlusive disease with claudication and surgery planning
Key inclusion criteria (4 listed)
- Peripheral arterial occlusive disease (PAOD) with claudication and surgery planning with proximal lesion (iliac or femoral (x-ray angiography or CT or MRA) and no distal lesions (doppler)
- ABI<0.90 or >1.30
- signed consent form
- health insurance coverage
Key exclusion criteria (8 listed)
- Contraindication in the practice of MRI: pacemaker, metallic cardiac valve, intra-ocular metal part, claustrophobia
- critical ischemia >15 days
- Type 1 or 2 diabetes
- weight >200kg
- non stabilized hypertension
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. | Device | PAOD patients statin (+), PAOD patients statin (-) |
Primary outcome
Muscle phosphocreatine (PCr) recovery time constant
Time frame: During the MRI procedure
Muscle phosphocreatine (PCr) recovery time constant (index of muscle aerobic capacity) after gated low-intensity exercise (2"maximum voluntary isometric dorsiflexion contractions, at 30s intervals for 8min (total contractions = 15)
2 secondary outcomes
Muscular volume and content
Time frame: During the MRI procedure
PCr recovery time constant
Time frame: During the MRI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Pierre CROISILLE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Arterial Occlusive Diseases, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre CROISILLE, PhD ((0)477127584 ext. +33, croisille@creatis.insa-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle phosphocreatine (PCr) recovery time constant (time frame: During the MRI procedure). 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 25 Apr 2024.