The Relationship Between Peripheral Arterial Disease and... | NCT02434783

Studies
The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

NCT02434783

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 5, 2016Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Intermittent Claudication

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2016

Last Update Posted Date

Aug 5, 2016Estimated

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Øyvind Rognmo	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Circulation and Medical Imaging		Trondheim			Norway

Condition Browse Module

MeSH Terms

ID	Term
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided