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The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434783
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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.

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.


Condition or disease
Intermittent Claudication

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
gastrocnemicus muscle biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434783


Locations
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Norway
Department of Circulation and Medical Imaging
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Øyvind Rognmo Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02434783    
Other Study ID Numbers: 2015/204
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Norwegian University of Science and Technology:
Blood circulation
Blood vessels
Mitochondria
Muscle, skeletal
Legs
Energy metabolism
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases