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NCT Number: NCT07785921

Health Behaviour and Readiness to Change After Myocardial Infarction: A Cross-sectional Survey

This study investigates health behaviour and readiness for lifestyle change in patients who recently had a heart attack (myocardical infarction) treated with stenting (PTCA). Despite successful acute treatment, many patients remain at increased risk of a second heart atttack because lifestyle changes are not consistently maintained. Participants who had a heart attack within the past 6 months will complete standardized questionnaires on readiness to change, quality of life, anxiety/depression, and physical functioning, plus a free-text section on personal barriers to change. Findings will characterize this population and inform a future lifestyle intervention trial

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Key information

Conditions

Cardiovascular (CV) Risk Cardiovascular Diseases Heart Attack Patients Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Cardiovascular diseses are the leading cause of deaths in Germany and worldwide. Even after successfull PTCA, reinfarction rates remain elevated, partly because patients often underestimate their ongoing risk, have limited knowledge of secondary prevention targets and show low self-efficacy for behavior change; anxiety and depression are also common after myocardial infarction.

This single-center, cross-sectional study enrolls patients treated with PTCA within the past 6 months, recruited during their routine follow-up visit at the Lipidambulanz, Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen. Participants complete validated questionnaires: PIAC (primary outcome; rediness to change), SF-36 (quality of life); HADS (anxiety/depression), and KCCQ-23 (physical functioning), plus sociodemographic data and free-text section on perceived barriers.

This study is purely observational, involves no interventions or biospecimens and takes about 30 minutes. A sample of 143 participants was calculated for adequate precision in estimating the PIAC meand and supporting exploratory regression analyses, accounting for 10% dropout. Data collection runs 6 months, followed by 18 months of analysus. Results wull inform a planned randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 18 years
  • myocardial infarction within past 6 months
  • PTCA treatment

Exclusion criteria

  • Age under 18
  • history of multiple myocardial infactionrs
  • myocardial infarction more than 6 months prior
  • myocardial infarction not treated by PTCA
  • absence of informed consent
  • severe cognitive impairment precluding data collection

Treatment and study plan

Primary outcomes

  1. PIAC (Perception, Intention and Ability to Change) Scale

    Time frame: Single assessement at study enrollment, baseline

    Readiness and ability to change health-related behavior, habits and living conditions, assessed using the PIAC questionnaire, a validated 9 item instrument covering awareness of negative health behaviors, intention to change and implementation of change strategies. Higher scores indicate a better awareness and intention to change.

Secondary outcomes

  1. SF-36 (Short-form 36 Health Survey)

    Time frame: Single assessement at study enrollment, baseline

    Health-related quality of life assessed using the SF-36, yielding a physical and a mental summary score; higher scores indicate better quality of life.

  2. HADS (Hospital Anxiety and Depression Scale)

    Time frame: Single assessement at study enrollment, baseline

    Anxiety and depressive Symptoms assessed using the HADS(-A) for Anxiety and HADS-(D) for depression. each ssubscales ranges from 0-21; higher scores indicate greater severity.

  3. KCCQ-23 (Kansas City Cardiomyopathy Questionnaire)

    Time frame: Single assessement at study enrollment, baseline

    Disease-specific health status using the KCCQ-23 covering physical limitations, symptoms, self-efficacy, social limitation and quality of life. Scores ranging 0-100 with higher scores indicating better health status.

Study contacts

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

Wiebke K Kohl-Heckl, Dr.med.

CONTACT

[email protected]

004920117425012

Sponsors and collaborators

Lead sponsor

Kliniken Essen-Mitte

Other

Collaborators

  • Universitätsklinikum Essen

Registry information

Official study title

Cardiovascular Risk Behavior and Readiness for Lifestyle Change After Myocardial Infarction: A Cross-sectional Questionnaire Study (HERZ-AKTIV)

Acronym: HerzAktiv

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 31, 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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