Intermittent ClaudicationNCT02434783
The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity
An observational study of Intermittent Claudication, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intermittent Claudication
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- May 2015to Apr 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with arterial insufficience at 1 of three levels, either asymptotic, intermittent claudication or critical limb ischemia; and healthy persons in a control group
Who may be able to join
- Asymptotic peripheral arterial disease (Ankle-brachial index < 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index < 0.4)
Who cannot join
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- Warfarin or heparin usage
- Underwent a vascular intervention in the last 6 months
- Active cancer, renal- or liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles.
This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.
- Conditions
- Intermittent Claudication
- Keywords
- Blood circulation, Blood vessels, Mitochondria, Muscle, skeletal, Legs, Energy metabolism
- Medical subject headings
- Intermittent Claudication
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 |
|---|---|---|
| 1st level of arterial insufficiency | asymptomatic PAD patients | |
| 2nd level of arterial insufficiency | Intermittent claudication patients | |
| 3rd level of arterial insufficiency | Critical limb ischemia patients | |
| No arterial insufficiency | Healthy individuals (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mitochondrial respiratory capacity
measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øyvind Rognmo, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434783
- Sponsor's protocol ID
- 2015/204
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2015
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity
- ClinicalTrials.gov ID
- NCT02434783
- Acronym / sponsor ID
- 2015/204
- Conditions
- Intermittent Claudication
- Keywords
- Blood circulation, Blood vessels, Mitochondria, Muscle, skeletal, Legs, Energy metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 May 2015 (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.
Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles.
This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1st level of arterial insufficiency | – | –asymptomatic PAD patients |
| 2nd level of arterial insufficiency | – | –Intermittent claudication patients |
| 3rd level of arterial insufficiency | – | –Critical limb ischemia patients |
| No arterial insufficiency | – | –Healthy individuals (control) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with arterial insufficience at 1 of three levels, either asymptotic, intermittent claudication or critical limb ischemia; and healthy persons in a control group
Key inclusion criteria (1 listed)
- Asymptotic peripheral arterial disease (Ankle-brachial index < 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index < 0.4)
Key exclusion criteria (4 listed)
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- Warfarin or heparin usage
- Underwent a vascular intervention in the last 6 months
- Active cancer, renal- or liver disease
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
mitochondrial respiratory capacity
Time frame: 1 hour
measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria).
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 5 Aug 2016.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Øyvind Rognmo study director
Norwegian University of Science and Technology
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 Intermittent Claudication, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 5 Aug 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 Norway. 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?
mitochondrial respiratory capacity (time frame: 1 hour). 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 5 Aug 2016.