Evaluation of Lifestyle Education and Events Via Network Text Messages After Acute Coronary Syndrome (Elena)

December 28, 2025 updated by: Fundación EPIC

Evaluation of Lifestyle Education and Events Via Network Text Messages After Acute Coronary Syndrome (Elena Trial)

To evaluate the usefulness of telephone text messages (TTM) in the control of risk factors and in the reduction of events in the first year after an ACS (acute coronary syndrome).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the usefulness of telephone text messages (TTM) in the control of risk factors and in the reduction of events in the first year after an ACS (acute coronary syndrome).

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cabueñes, Spain
        • Hospital Universitario de Cabueñes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients discharged with ACS and without ST elevation.
  • Informed consent signed.

Exclusion Criteria:

  • Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Behavioral: Usual Care
The patient received followed the usual review protocol in a specific ischemic heart disease consultation at 3 and 12 months after discharge.
Experimental: Text messaging group with usual care
Other: Text messaging and Usual Care
The patient received a monthly telephone text messages (TTM) for 12 months with the recommendations of the Spanish Society of Cardiology regarding secondary prevention and followed the usual review protocol in a specific ischemic heart disease consultation at 3 and 12 months after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of cardiac death, myocardial infarction, stroke or new revascularization
Time Frame: 12 months
Occurrence of Composite of cardiac death, myocardial infarction, stroke or new revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure (SBP) mm Hg
Time Frame: 12 months
Mean of SBP
12 months
Diastolic blood pressure (DBP) (mm Hg)
Time Frame: 12 months
Mean of DBP
12 months
Change in Weight (kilograms)
Time Frame: 12 months
Mean of Change in Weight
12 months
Low Density Lipoproteins (LDL) cholesterol (mg/dl)
Time Frame: 12 months
Mean of LDL
12 months
High (HDL) cholesterol (mg/dl)
Time Frame: 12 months
Mean of LDL
12 months
Triglycerides (mg/dl)
Time Frame: 12 months
Mean of Triglycerides
12 months
Glycosylated hemoglobin (%)
Time Frame: 12 months
Mean of Glycosylated hemoglobin
12 months
Active smoking
Time Frame: 12 months
Percentage of Active smoking
12 months
Exercise per week (hours)
Time Frame: 12 months
Mean of Exercise per week
12 months
Total Death
Time Frame: 12 months
Occurrence of All Death
12 months
Cardiac Death
Time Frame: 12 months
Occurrence of Cardiovascular Death
12 months
Myocardial Infarction
Time Frame: 12 months
Occurrence of Myocardial Infarction
12 months
Stroke
Time Frame: 12 months
Occurrence of Stroke
12 months
New revascularization
Time Frame: 12 month
Occurrence of New revascularization
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC50-Elena Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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