NCT04294940

Brief Summary

Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost. After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting. Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle. A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement. Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max. The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR. The mobile application CardiCare™ consists of several modules:

  • A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm
  • Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life
  • Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit
  • Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
4 countries

10 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

February 25, 2020

Last Update Submit

June 24, 2021

Conditions

Acute Coronary Syndrome

Keywords

CardiCareCoronary heart diseaseApplicationMobileAcute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care.

    Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A

    From day 0 to month 6

Secondary Outcomes (22)

  • To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up.

    From day 0 to month 6

  • To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups.

    From day 0 to month 3

  • To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups

    From day 0 to month 3 and month 6

  • To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups.

    From day 0 to month 3 and month 6

  • To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups.

    From day 0 to month 3 and month 6

  • +17 more secondary outcomes

Study Arms (2)

Group A: standard of care

OTHER

The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day.

Other: Wear an actigraph

Group B: standard of care + mobile application CardiCare™

OTHER

The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™

Other: Use the mobile application CardiCare™ and wear an actigraph

Interventions

Wear an actigraphOTHER

Between visits, tha patient will have to: * Follow the hygiene-dietetic recommendations given by their centre. * Wear the actigraph night and day Patients

Group A: standard of care
Use the mobile application CardiCare™ and wear an actigraphOTHER

Between visits, tha patient will have to: * Follow the hygiene-dietetic recommendations given by their centre. * Wear the actigraph night and day Patients * wear their smartphone everyday and use the mobile application CardiCare™

Group B: standard of care + mobile application CardiCare™

Eligibility Criteria

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

You may qualify if:

  • Subjects ≥ 18 years old.
  • Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report.
  • Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home.
  • Owning a personal smartphone (Android 5.0 or beyond / iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G/4G).
  • Able to use a smartphone (e.g. no vision, hearing, cognitive or dexterity impairment).
  • Having agreed to install CardiCare™ application on their own smartphone.
  • Having agreed to wear an actigraph at all times and install the actigraph application (CenterPoint Sync) on their smartphone.
  • Enrolled in or benefiting of a national health system.
  • Having read the information sheet and signed the informed consent form.
  • Treated with Coronary Artery Bypass Grafting.
  • Cardiac surgery in the last 12 weeks.
  • Planned revascularisation or surgery in the next 6 months.
  • Clinical heart failure or Left Ventricular Ejection Fraction \< 40% documented within the last 2 months.
  • Severe valvular disease.
  • Severe pulmonary disease.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Corentin Celton hospital

Issy-les-Moulineaux, France

Location

Lariboisière hospital

Paris, France

Location

Saint-Yves clinic

Rennes, France

Location

Brie Cardiac Readaptation Centre

Villeneuve-Saint-Denis, France

Location

Maugeri Scientific Clinical Institutes

Pavia, Italy

Location

Scientific Institute of Hospitalization and Care San Raffaele Pisana

Roma, Italy

Location

CHOL - Santa Cruz hospital

Carnaxide, Portugal

Location

CHULN - Santa Marta hospital

Lisbon, Portugal

Location

Carlos III - La Paz Hospital

Madrid, Spain

Location

Santiago University Hospital

Santiago de Compostela, Spain

Location

Related Publications (1)

  • Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

    PMID: 34741536DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Alain Cohen Solal, Prof

    Lariboisière Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 4, 2020

Study Start

December 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

IT(2)FR(4)PT(2)ES(2)