NCT01812343

Brief Summary

Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease. Estimate morbi-mortality of included patients over a 5 years follow up.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,760

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
Last Updated

August 2, 2022

Status Verified

November 1, 2019

Enrollment Period

10.7 years

First QC Date

March 4, 2013

Last Update Submit

July 28, 2022

Conditions

Cardiovascular Diseases

Keywords

Ankle Brachial IndexMaximal Exercise Test

Outcome Measures

Primary Outcomes (1)

  • Mean value of post exercise ABI by age categories

    Ankle to brachial index is measured before and after a maximal exercise on a cycle ergometer. results are expressed by age categories of 10 years interval

    up to 15min

Secondary Outcomes (1)

  • Prevalence of Morbi-mortality through self completed questionnaires

    up to 5 year

Study Arms (1)

Exercise test

OTHER

Ankle pressure Index measure before and after Maximal Exercise Tests

Other: Exercise test

Interventions

Exercise testOTHER
Exercise test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and more

You may not qualify if:

  • patient with recent cardiovascular event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHAngers

Angers, 49933, France

Location

Related Publications (1)

  • Congnard F, Abraham P, Vincent F, Le Tourneau T, Carre F, Hupin D, Hamel JF, Vielle B, Bruneau A. Ankle to brachial systolic pressure index at rest increases with age in asymptomatic physically active participants. BMJ Open Sport Exerc Med. 2015 Nov 25;1(1):e000081. doi: 10.1136/bmjsem-2015-000081. eCollection 2015.

    PMID: 27900144DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Pierre ABRAHAM, PU-PH

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 18, 2013

Study Start

September 17, 2009

Primary Completion

May 11, 2020

Study Completion

May 11, 2020

Last Updated

August 2, 2022

Record last verified: 2019-11

Locations

FR(1)