Intra-arterial Measurement of pO2 in Walking Induced Tran... | NCT01022606

Studies
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles

NCT01022606

Sponsor

University Hospital, Angers

Status

Terminated

Last Update Posted

Mar 18, 2013Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Claudication

Interventions

Arterial sampling

Countries

France

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped for one complication event (arterial occlusion)

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Dec 1, 2009Estimated

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

Mar 15, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Detailed Description

Arterial PO2 and body temperature measurements during exercise

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with walking limitation	Other	Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording	Other: Arterial sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arterial sampling	Other	Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400	Patients with walking limitation

Measure	Description	Time Frame
arterial pO2		2 months (time required to organise the test)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

walking induced transient Hack (WITH) tcpO2 profile

Exclusion Criteria:

rejection by patient

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
P Abraham, MD, PhD	University Hospital	Study Chair

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