Acute Coronary SyndromeElenaNCT07331415
Evaluation of Lifestyle Education and Events Via Network Text Messages After Acute Coronary Syndrome
A study of Acute Coronary Syndrome and Myocardial Infarction, run by Fundación EPIC at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Cardiovascular Diseases
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients discharged with ACS and without ST elevation.
- Informed consent signed.
Who cannot join
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Being tested
- Text messaging and Usual Care, Usual Care
- Keywords
- Text messaging, Usual care
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messaging and Usual CareOther
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.
Usual CareBehavioural
The patient received followed the usual review protocol in a specific ischemic heart disease consultation at 3 and 12 months after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Text messaging group with usual care | Experimental | Not described Receives: Other: Text messaging and Usual Care |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death, myocardial infarction, stroke or new revascularization
Occurrence of Composite of cardiac death, myocardial infarction, stroke or new revascularization
Measured: 12 months
Secondary outcomes (14)
Systolic blood pressure (SBP) mm Hg
Mean of SBP
Measured: 12 months
Diastolic blood pressure (DBP) (mm Hg)
Mean of DBP
Measured: 12 months
Change in Weight (kilograms)
Mean of Change in Weight
Measured: 12 months
Low Density Lipoproteins (LDL) cholesterol (mg/dl)
Mean of LDL
Measured: 12 months
High (HDL) cholesterol (mg/dl)
Mean of LDL
Measured: 12 months
Triglycerides (mg/dl)
Mean of Triglycerides
Measured: 12 months
Glycosylated hemoglobin (%)
Mean of Glycosylated hemoglobin
Measured: 12 months
Active smoking
Percentage of Active smoking
Measured: 12 months
Exercise per week (hours)
Mean of Exercise per week
Measured: 12 months
Total Death
Occurrence of All Death
Measured: 12 months
Cardiac Death
Occurrence of Cardiovascular Death
Measured: 12 months
Myocardial Infarction
Occurrence of Myocardial Infarction
Measured: 12 months
Stroke
Occurrence of Stroke
Measured: 12 months
New revascularization
Occurrence of New revascularization
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 May 2019
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331415
- Sponsor's protocol ID
- EPIC50-Elena Trial
- Acronym
- Elena
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.
PubMed 23349621Sharma P APMptm, in fpatat, en/ pwHiRchawirhacsc, 2015). aF.
Anglada-Martinez H, Riu-Viladoms G, Martin-Conde M, Rovira-Illamola M, Sotoca-Momblona JM, Codina-Jane C. Does mHealth increase adherence to medication? Results of a systematic review. Int J Clin Pract. 2015 Jan;69(1):9-32. doi: 10.1111/ijcp.12582. Epub 2014 Dec 4.
PubMed 25472682Adler AJ, Casas JP, Martin N, Free C, Perel P. Cochrane corner: text messaging to improve adherence to drugs for secondary prevention of cardiovascular disease. Heart. 2018 Nov;104(22):1814-1816. doi: 10.1136/heartjnl-2017-312888. Epub 2018 May 14. No abstract available.
PubMed 29760242Senatore FF, Califf RM. Standardized classification and framework for reporting and interpreting medication non-adherence in clinical trials. Eur Heart J. 2019 Jul 1;40(25):2086-2088. doi: 10.1093/eurheartj/ehy759. No abstract available.
PubMed 30496403
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lifestyle Education and Events Via Network Text Messages After Acute Coronary Syndrome (Elena Trial)
- ClinicalTrials.gov ID
- NCT07331415
- Acronym / sponsor ID
- Elena / EPIC50-Elena Trial
- Keywords
- Text messaging, Usual care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messaging group with usual care | Experimental | Other: Text messaging and Usual Care |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients discharged with ACS and without ST elevation.
- Informed consent signed.
Key exclusion criteria (1 listed)
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messaging and Usual CareThe 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. | Other | Text messaging group with usual care |
| Usual CareThe patient received followed the usual review protocol in a specific ischemic heart disease consultation at 3 and 12 months after discharge. | Behavioural | Usual Care |
Primary outcome
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
14 secondary outcomes
Systolic blood pressure (SBP) mm Hg
Time frame: 12 months
Diastolic blood pressure (DBP) (mm Hg)
Time frame: 12 months
Change in Weight (kilograms)
Time frame: 12 months
Low Density Lipoproteins (LDL) cholesterol (mg/dl)
Time frame: 12 months
High (HDL) cholesterol (mg/dl)
Time frame: 12 months
Triglycerides (mg/dl)
Time frame: 12 months
Glycosylated hemoglobin (%)
Time frame: 12 months
Active smoking
Time frame: 12 months
Exercise per week (hours)
Time frame: 12 months
Total Death
Time frame: 12 months
Cardiac Death
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Stroke
Time frame: 12 months
New revascularization
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 23349621Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.
- BackgroundSharma P APMptm, in fpatat, en/ pwHiRchawirhacsc, 2015). aF.
- Background: PubMed 25472682Anglada-Martinez H, Riu-Viladoms G, Martin-Conde M, Rovira-Illamola M, Sotoca-Momblona JM, Codina-Jane C. Does mHealth increase adherence to medication? Results of a systematic review. Int J Clin Pract. 2015 Jan;69(1):9-32. doi: 10.1111/ijcp.12582. Epub 2014 Dec 4.
- Background: PubMed 29760242Adler AJ, Casas JP, Martin N, Free C, Perel P. Cochrane corner: text messaging to improve adherence to drugs for secondary prevention of cardiovascular disease. Heart. 2018 Nov;104(22):1814-1816. doi: 10.1136/heartjnl-2017-312888. Epub 2018 May 14. No abstract available.
- Background: PubMed 30496403Senatore FF, Califf RM. Standardized classification and framework for reporting and interpreting medication non-adherence in clinical trials. Eur Heart J. 2019 Jul 1;40(25):2086-2088. doi: 10.1093/eurheartj/ehy759. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Coronary Syndrome and Myocardial Infarction, run by Fundación EPIC at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiac death, myocardial infarction, stroke or new revascularization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07331415, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.