NCT06701032

Brief Summary

The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program). Also, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

November 20, 2024

Last Update Submit

August 17, 2025

Conditions

Keywords

cardiovascular rehabilitationsupervised exercise therapysecondary preventioncardiovascular secondary preventioncardiovascular rehabilitation programhemodynamics of lower limbstoe pressure measurement

Outcome Measures

Primary Outcomes (3)

  • Change in toe pressure measurement

    Results will be measured in mm Hg

    Change from baseline to 12 weeks

  • Change in the toe-brachial index

    Change from baseline to 12 weeks

  • Change in the ankle-brachial index

    Change from baseline to 12 weeks

Secondary Outcomes (2)

  • Change in 6-minute walk test (6MWT)

    Change from Baseline to 12 weeks

  • Short Form Health Survey 36 (SF-36)

    Change from baseline to 12 weeks

Study Arms (1)

Cardiovascular rehabilitation program

EXPERIMENTAL
Other: Cardiovascular rehabilitation program

Interventions

The cardiovascular rehabilitation program consists of a 12 weeks supervised exercises therapy (either in person or in tele-care)

Cardiovascular rehabilitation program

Eligibility Criteria

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

You may qualify if:

  • Any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic);
  • Have been admitted to the PREV program;

You may not qualify if:

  • Being not able to give written informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLSC de Lévis - Programme PREV du CISSS de Chaudière-Appalaches

Lévis, Quebec, G6V 0M4, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseCoronary Artery DiseaseAngina PectorisMyocardial Infarction

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

November 25, 2024

Primary Completion

August 29, 2025

Study Completion

March 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations