NCT02619422

Brief Summary

To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

October 4, 2015

Last Update Submit

June 5, 2018

Conditions

Acute Coronary Syndrome

Keywords

Cardiac rehabilitation programsAdherence to secondary preventive measuresAcute coronary syndromeMore intensive cardiac rehabilitation program in less time

Outcome Measures

Primary Outcomes (4)

  • Adherence to physical exercise

    Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry

    baseline-12 months

  • Adherence to Mediterranean diet

    Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)

    baseline-12 months

  • Tabacco abstinence

    Assessed by cooximetry (less dan 10 ppm)

    baseline-12 months

  • Number of participants reporting compliance with prescribed treatments

    Patient-reported answers form the investigator

    baseline-12 months

Study Arms (2)

Intensivo

OTHER

intensive cardiac rehabilitation program in less time

Other: Intensive cardiac rehabilitation program in less time

Convencional

NO INTERVENTION

standard cardiac rehabilitation program

Interventions

Intensive cardiac rehabilitation program in less timeOTHER

2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months

Intensivo

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Equal or older 18 years old
  • Acute coronary syndrome with or without ST elevation within last two months
  • Being able to do physical exercise
  • Being able to understand the educative sessions
  • Being able to understand patient information in the consent form

You may not qualify if:

  • Hemodynamic instability
  • Left ventricular ejection fraction (LVEF) \< or = 35%
  • Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
  • Refractory angina
  • Any pathology for which physical exercise is not indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 08046, Spain

Location

Related Publications (1)

  • Castro-Conde A, Abeytua M, Arrarte Esteban VI, Caravaca Perez P, Dalmau Gonzalez-Gallarza R, Garza Benito F, Hidalgo Urbano RJ, Torres Marques J, Vidal-Perez R, Nunez-Gil IJ. Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Mas por Menos) randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):518-525. doi: 10.1016/j.rec.2020.03.029. Epub 2020 Aug 15. English, Spanish.

    PMID: 32807709DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Cardiology Department Staff, Hospital Universitario La Paz , Madrid

Study Record Dates

First Submitted

October 4, 2015

First Posted

December 2, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 28, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

ES(1)