Myocardial InfarctionNCT07402642
Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome
A study testing Motivational and Individualized Interviewing, Heart-Healthy Dietary Education and Tobacco Cessation Approach in people with Myocardial Infarction, run by Sergio Mies Padilla at 1 site in Spain.
Trial summary
Early Education After a Heart Attack What is the purpose of this study? The main goal is to evaluate if a special nursing education and support program helps patients who have suffered a heart attack feel more confident in managing their own health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Motivational and Individualized Interviewing, Heart-Healthy Dietary Education and Tobacco Cessation Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 must have suffered an Acute Myocardial Infarction.
- Participants must have undergone an urgent cardiac catheterization.
- Specifically, this includes patients who received coronary reperfusion strategies following the activation of the CODICAN protocol (assistance for ST-segment elevation myocardial infarction) within the study environment.
Who cannot join
- Patients with little or no knowledge of the Spanish language that prevents effective communication or reading of educational resources.
- Patients unable to understand their participation or follow health recommendations independently.
- Patients with an unfavorable clinical prognosis or those requiring hospitalization for a period exceeding established limits.
- Patients unable to attend in-person nursing consultations due to personal reasons or place of residence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35001
Jose Manuel García, Cardiology Supervisor, +34928444000 (ext: 71363), jgarhery@gobiernodecanarias.org
About this study
Early Education After a Heart Attack What is the purpose of this study? The main goal is to evaluate if a special nursing education and support program helps patients who have suffered a heart attack feel more confident in managing their own health. Researchers want to see if this extra support improves how patients care for their hearts through diet, physical activity, and quitting smoking. The study compares this new nursing strategy against the standard care patients usually receive.
Who can participate? Participants must be 18 years of age or older. People who have recently had a heart attack requiring an urgent heart catheterization at the Complejo Hospitalario Universitario Insular Materno Infantil.
Read more
Exclusions: People with significant language barriers (Spanish), mental incapacity to follow recommendations, or those unable to attend in-person consultations cannot participate.
What will happen during the study? Participants will be divided into two groups: Standard Care Group (Control): These participants will receive the usual medical follow-up and standard cardiac rehabilitation sessions (an average of 17 sessions focused on exercise and group education). Special Support Group (Experimental): In addition to standard care, these participants will have a specific nursing consultation consisting of 4 scheduled visits.
These visits are a mix of in-person and telephone appointments.Nurses will provide personalized educational materials, such as infographics, and teach techniques to control blood pressure, improve diet, exercise safely, and manage emotions after a heart attack.
Duration and Follow-up Each participant will be followed for approximately 8 months. During this time, they will be asked to complete several surveys about their lifestyle.
Researchers will also review blood test results (cholesterol levels) from their medical records to track progress.
- Conditions
- Myocardial Infarction
- Being tested
- Motivational and Individualized Interviewing, Heart-Healthy Dietary Education, Tobacco Cessation Approach, Physical Activity Promotion, Emotional Health Management
- Keywords
- Patient Education, Secondary Prevention, Nursing Care, Self Efficacy, risk factors, Healthy Lifestyle, Cardiovascular Diseases
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational and Individualized InterviewingBehavioural
Used to verify the patient's understanding of their condition and to motivate behavioral changes.
Heart-Healthy Dietary EducationBehavioural
Specific counseling to improve adherence to the Mediterranean diet and address overweight or obesity
Tobacco Cessation ApproachBehavioural
Interventions aimed at increasing motivation to quit smoking and reducing nicotine dependence
Physical Activity PromotionBehavioural
Personalized exercise recommendations tailored to the patient's clinical status
Emotional Health ManagementBehavioural
Professional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event.
Therapeutic Adherence ReinforcementBehavioural
Continuous education and monitoring to ensure compliance with the prescribed pharmacological plan
Self-Control TrainingBehavioural
Training the patient for autonomous monitoring of risk factors, such as blood pressure
Use of Educational ResourcesBehavioural
Provision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors
Cardiac Rehabilitation ProgramOther
Upon hospital discharge, all patients are referred to a cardiac rehabilitation unit. The program consists of an average of 17 sessions focused primarily on the physical rehabilitation of the patient. Patients receive group-based health education provided by nursing professionals during these sessions.These rehabilitation sessions are typically completed within three months following the coronary event. Patients continue to receive medical and nursing attention through specialized care centers or primary care. Both groups receive optimal pharmacological treatment and general advice on cardiovascular health, including physical activity and diet.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The intervention for the experimental group consists of specialized and structured nursing care provided in addition to standard medical treatment. This program is organized into four key stages: it begins with an initial contact during hospital admission to explain the objectives and assess baseline risks. Subsequently, between 7 and 10 days after discharge, a 60-minute in-person visit is conducted to perform a complete medical history and deliver adapted educational materials on heart-healthy habits. Four months after the event, a telephone reinforcement session is held to monitor treatment adherence and lifestyle changes. Finally, eight months after discharge, an in-person evaluation is carried out to measure the achievement of goals and, if necessary, refer the patient to other specialists. The entire process is supported by the use of infographics and evidence-based educational materials focused on blood pressure control, diet, exercise, and emotional health. Receives: Behavioral: Motivational and Individualized Interviewing; Behavioral: Heart-Healthy Dietary Education; Behavioral: Tobacco Cessation Approach; Behavioral: Physical Activity Promotion; Behavioral: Emotional Health Management; Behavioral: Therapeutic Adherence Reinforcement; Behavioral: Self-Control Training; Behavioral: Use of Educational Resources; Other: Cardiac Rehabilitation Program |
| Control Group | Active comparator | The Control Group consists of patients who receive the standard healthcare provided by the hospital after a heart attack. These participants are recruited retrospectively using the hospital's hemodynamic service records. After discharge, they participate in the standard cardiac rehabilitation program, which typically includes 17 sessions of physical exercise and group health education. Their data is collected through a single telephone interview approximately 8 months after their heart attack to evaluate their lifestyle habits, emotional state, and clinical progress. Receives: Other: Cardiac Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Self-Efficacy
His measure evaluates specific behaviors related to cardiovascular health using the Spanish-validated version of the Cardiac Self-Efficacy Scale (S-CSE). This tool consists of 12 items across three dimensions: symptom control, disease control, and activity maintenance. Each item is rated on a 7-point Likert scale (1 = not at all confident, 7 = completely confident). Total scores range from 12 to 84, where higher scores indicate better self-efficacy
Measured: Experimental Group: measured at two time points: baseline (during hospitalization) and 8 months (post-coronary event). Control Group: measured only at the 8-month mark post-coronary event to evaluate the level of self-efficacy after receiving standard
Secondary outcomes (7)
Adherence to the Mediterranean Diet
Measured using the MEDAS questionnaire (14 items). Higher scores indicate greater adherence to a heart-healthy diet
Measured: Experimental Group: baseline and 8 months Control Group: 8 months only
Nicotine Dependence
Assessed using the Fagerström Test (6 items). Scores range from 0 to 10, where greater than or equal to 7 indicates high dependence
Measured: Experimental Group: baseline and 8 months Control Group: 8 months only
Motivation to Quit Smoking
Evaluated through the Richmond Test (4 items). Scores range from 0 to 10; scores between 8-10 indicate high motivation.
Measured: Experimental Group: Baseline and 8 months . Control Group: 8 months only.
Physical Activity Level
Measured using the International Physical Activity Questionnaire (IPAQ). It categorizes patients into high, moderate, or low activity levels based on METs.
Measured: Experimental Group: Baseline and 8 months Control Group: 8 months only.
Affective State (Anxiety and Depression)
Determined using the Goldberg Scale. It consists of two subscales (anxiety mayor o igual a 4 and depression greater than or equal to 2) to detect psychological distress
Measured: Experimental Group: Baseline and 8 months Control Group: 8 months only
Lipid Profile
Clinical data collection of total cholesterol, LDL, HDL, and triglycerides from medical records
Measured: Experimental Group: Baseline and 8 months Control Group: 8 months only
Cardiac Rehabilitation Adherence
Exploration of patient inclusion, adherence (number of sessions attended), and group education received
Measured: 8 months (for both groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start12 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study model designed for your research is defined as a quasi-experimental parallel group trial. In this design, participants are divided into two branches that progress simultaneously but independently, receiving different levels of care. Experimental Group (Prospective Recruitment): participants receive standard medical care plus a structured, protocol-based nursing consultation. Control Group (Retrospective Recruitment): participants receive standard care only, which includes the conventional cardiac rehabilitation program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergio Mies Padilla
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil
- Responsible party
- Sponsor-investigator, Sergio Mies Padilla, Servicio Canario de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402642
- Sponsor's protocol ID
- 2025-519-1
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to share individual participant data (IPD) with external researchers or public platforms. According to the protocol, the collected data will be used exclusively for the research purposes of this specific study, and only the research team will have access to the anonymized database. Patient privacy is protected by current regulations (Spanish Organic Law 3/2018), ensuring that information is treated confidentially and securely within the hospital environment.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07402642
- Acronym / sponsor ID
- 2025-519-1
- Conditions
- Myocardial Infarction
- Keywords
- Patient Education, Secondary Prevention, Nursing Care, Self Efficacy, risk factors, Healthy Lifestyle, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sergio Mies PadillaUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Feb 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.
Early Education After a Heart Attack What is the purpose of this study? The main goal is to evaluate if a special nursing education and support program helps patients who have suffered a heart attack feel more confident in managing their own health. Researchers want to see if this extra support improves how patients care for their hearts through diet, physical activity, and quitting smoking. The study compares this new nursing strategy against the standard care patients usually receive.
Who can participate? Participants must be 18 years of age or older. People who have recently had a heart attack requiring an urgent heart catheterization at the Complejo Hospitalario Universitario Insular Materno Infantil.
Exclusions: People with significant language barriers (Spanish), mental incapacity to follow recommendations, or those unable to attend in-person consultations cannot participate.
What will happen during the study? Participants will be divided into two groups: Standard Care Group (Control): These participants will receive the usual medical follow-up and standard cardiac rehabilitation sessions (an average of 17 sessions focused on exercise and group education). Special Support Group (Experimental): In addition to standard care, these participants will have a specific nursing consultation consisting of 4 scheduled visits.
These visits are a mix of in-person and telephone appointments.Nurses will provide personalized educational materials, such as infographics, and teach techniques to control blood pressure, improve diet, exercise safely, and manage emotions after a heart attack.
Duration and Follow-up Each participant will be followed for approximately 8 months. During this time, they will be asked to complete several surveys about their lifestyle.
Researchers will also review blood test results (cholesterol levels) from their medical records to track progress.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study model designed for your research is defined as a quasi-experimental parallel group trial. In this design, participants are divided into two branches that progress simultaneously but independently, receiving different levels of care. Experimental Group (Prospective Recruitment): participants receive standard medical care plus a structured, protocol-based nursing consultation. Control Group (Retrospective Recruitment): participants receive standard care only, which includes the conventional cardiac rehabilitation program
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Motivational and Individualized Interviewing, Behavioral: Heart-Healthy Dietary Education, Behavioral: Tobacco Cessation Approach, Behavioral: Physical Activity Promotion, Behavioral: Emotional Health Management, Behavioral: Therapeutic Adherence Reinforcement, Behavioral: Self-Control Training, Behavioral: Use of Educational Resources, Other: Cardiac Rehabilitation ProgramThe intervention for the experimental group consists of specialized and structured nursing care provided in addition to standard medical treatment. This program is organized into four key stages: it begins with an initial contact during hospital admission to explain the objectives and assess baseline risks. Subsequently, between 7 and 10 days after discharge, a 60-minute in-person visit is conducted to perform a complete medical history and deliver adapted educational materials on heart-healthy habits. Four months after the event, a telephone reinforcement session is held to monitor treatment adherence and lifestyle changes. Finally, eight months after discharge, an in-person evaluation is carried out to measure the achievement of goals and, if necessary, refer the patient to other specialists. The entire process is supported by the use of infographics and evidence-based educational materials focused on blood pressure control, diet, exercise, and emotional health. |
| Control Group | Active comparator | Other: Cardiac Rehabilitation ProgramThe Control Group consists of patients who receive the standard healthcare provided by the hospital after a heart attack. These participants are recruited retrospectively using the hospital's hemodynamic service records. After discharge, they participate in the standard cardiac rehabilitation program, which typically includes 17 sessions of physical exercise and group health education. Their data is collected through a single telephone interview approximately 8 months after their heart attack to evaluate their lifestyle habits, emotional state, and clinical progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have suffered an Acute Myocardial Infarction.
- Participants must have undergone an urgent cardiac catheterization.
- Specifically, this includes patients who received coronary reperfusion strategies following the activation of the CODICAN protocol (assistance for ST-segment elevation myocardial infarction) within the study environment.
Key exclusion criteria (4 listed)
- Patients with little or no knowledge of the Spanish language that prevents effective communication or reading of educational resources.
- Patients unable to understand their participation or follow health recommendations independently.
- Patients with an unfavorable clinical prognosis or those requiring hospitalization for a period exceeding established limits.
- Patients unable to attend in-person nursing consultations due to personal reasons or place of residence
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 |
|---|---|---|
| Motivational and Individualized InterviewingUsed to verify the patient's understanding of their condition and to motivate behavioral changes. | Behavioural | Experimental Group |
| Heart-Healthy Dietary EducationSpecific counseling to improve adherence to the Mediterranean diet and address overweight or obesity | Behavioural | Experimental Group |
| Tobacco Cessation ApproachInterventions aimed at increasing motivation to quit smoking and reducing nicotine dependence | Behavioural | Experimental Group |
| Physical Activity PromotionPersonalized exercise recommendations tailored to the patient's clinical status | Behavioural | Experimental Group |
| Emotional Health ManagementProfessional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event. | Behavioural | Experimental Group |
| Therapeutic Adherence ReinforcementContinuous education and monitoring to ensure compliance with the prescribed pharmacological plan | Behavioural | Experimental Group |
| Self-Control TrainingTraining the patient for autonomous monitoring of risk factors, such as blood pressure | Behavioural | Experimental Group |
| Use of Educational ResourcesProvision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors | Behavioural | Experimental Group |
| Cardiac Rehabilitation ProgramUpon hospital discharge, all patients are referred to a cardiac rehabilitation unit. The program consists of an average of 17 sessions focused primarily on the physical rehabilitation of the patient. Patients receive group-based health education provided by nursing professionals during these sessions.These rehabilitation sessions are typically completed within three months following the coronary event. Patients continue to receive medical and nursing attention through specialized care centers or primary care. Both groups receive optimal pharmacological treatment and general advice on cardiovascular health, including physical activity and diet. | Other | Control Group, Experimental Group |
Primary outcome
Cardiac Self-Efficacy
Time frame: Experimental Group: measured at two time points: baseline (during hospitalization) and 8 months (post-coronary event). Control Group: measured only at the 8-month mark post-coronary event to evaluate the level of self-efficacy after receiving standard
His measure evaluates specific behaviors related to cardiovascular health using the Spanish-validated version of the Cardiac Self-Efficacy Scale (S-CSE). This tool consists of 12 items across three dimensions: symptom control, disease control, and activity maintenance. Each item is rated on a 7-point Likert scale (1 = not at all confident, 7 = completely confident). Total scores range from 12 to 84, where higher scores indicate better self-efficacy
7 secondary outcomes
Adherence to the Mediterranean Diet
Time frame: Experimental Group: baseline and 8 months Control Group: 8 months only
Nicotine Dependence
Time frame: Experimental Group: baseline and 8 months Control Group: 8 months only
Motivation to Quit Smoking
Time frame: Experimental Group: Baseline and 8 months . Control Group: 8 months only.
Physical Activity Level
Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only.
Affective State (Anxiety and Depression)
Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only
Lipid Profile
Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only
Cardiac Rehabilitation Adherence
Time frame: 8 months (for both groups)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. Currently, there is no plan to share individual participant data (IPD) with external researchers or public platforms. According to the protocol, the collected data will be used exclusively for the research purposes of this specific study, and only the research team will have access to the anonymized database. Patient privacy is protected by current regulations (Spanish Organic Law 3/2018), ensuring that information is treated confidentially and securely within the hospital environment.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational and Individualized Interviewing, Heart-Healthy Dietary Education and Tobacco Cessation Approach in people with Myocardial Infarction, run by Sergio Mies Padilla 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Mies Padilla (+34928478880, smiepad@gobiernodecanarias.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Self-Efficacy (time frame: Experimental Group: measured at two time points: baseline (during hospitalization) and 8 months (post-coronary event). Control Group: measured only at the 8-month mark post-coronary event to evaluate the level of self-efficacy after receiving standard). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.