The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

NCT02434783 | Completed

• 1 other identifier: 2015/204
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Keywords

Blood circulation; Blood vessels; Mitochondria; Muscle, skeletal; Legs; Energy metabolism

Outcome Measures

Primary Outcomes (1)

• mitochondrial respiratory capacity

  measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria).

  1 hour

Study Arms (4)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

gastrocnemicus muscle biopsy

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Øyvind Rognmo

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

NO (1)