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NCT Number: NCT07402642

Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

Location status: Recruiting

Location contact

Jose Manuel García, Cardiology Supervisor

CONTACT

[email protected]

+34928444000 (ext: 71363)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Motivational and Individualized Interviewing

Behavioral

Used to verify the patient's understanding of their condition and to motivate behavioral changes.

Heart-Healthy Dietary Education

Behavioral

Specific counseling to improve adherence to the Mediterranean diet and address overweight or obesity

Tobacco Cessation Approach

Behavioral

Interventions aimed at increasing motivation to quit smoking and reducing nicotine dependence

Physical Activity Promotion

Behavioral

Personalized exercise recommendations tailored to the patient's clinical status

Emotional Health Management

Behavioral

Professional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event.

Therapeutic Adherence Reinforcement

Behavioral

Continuous education and monitoring to ensure compliance with the prescribed pharmacological plan

Self-Control Training

Behavioral

Training the patient for autonomous monitoring of risk factors, such as blood pressure

Use of Educational Resources

Behavioral

Provision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors

Cardiac rehabilitation program

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Adherence to the Mediterranean Diet

    Time frame: Experimental Group: baseline and 8 months Control Group: 8 months only

    Measured using the MEDAS questionnaire (14 items). Higher scores indicate greater adherence to a heart-healthy diet

  2. Nicotine Dependence

    Time frame: Experimental Group: baseline and 8 months Control Group: 8 months only

    Assessed using the Fagerström Test (6 items). Scores range from 0 to 10, where greater than or equal to 7 indicates high dependence

  3. Motivation to Quit Smoking

    Time frame: Experimental Group: Baseline and 8 months . Control Group: 8 months only.

    Evaluated through the Richmond Test (4 items). Scores range from 0 to 10; scores between 8-10 indicate high motivation.

  4. Physical Activity Level

    Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only.

    Measured using the International Physical Activity Questionnaire (IPAQ). It categorizes patients into high, moderate, or low activity levels based on METs.

  5. Affective State (Anxiety and Depression)

    Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only

    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

  6. Lipid Profile

    Time frame: Experimental Group: Baseline and 8 months Control Group: 8 months only

    Clinical data collection of total cholesterol, LDL, HDL, and triglycerides from medical records

  7. Cardiac Rehabilitation Adherence

    Time frame: 8 months (for both groups)

    Exploration of patient inclusion, adherence (number of sessions attended), and group education received

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina María Torres Moreno

CONTACT

[email protected]

+34928444000 (ext:71363)

Sergio Mies Padilla

CONTACT

[email protected]

+34928478880

Sponsors and collaborators

Lead sponsor

Sergio Mies Padilla

Other

Collaborators

  • Complejo Hospitalario Universitario Insular Materno Infantil

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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