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Cardiovascular (CV) RiskHerzAktivNCT07785921

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

An observational study of Cardiovascular (CV) Risk and Heart Attack Patients, run by Kliniken Essen-Mitte at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
143 participants
Where
1 siteGermany
Study dates
15 Sep 2026to 30 Sep 2028
Phase
Observational
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

Study population: Patients from the catchment area of the Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen, treated for acute myocardial infarction with PTCA. Recruitment and eligibility screening take place during the routine post-discharge follow-up visit at the Lipidambulanz, within approx. 3 months. after the index event. creening is performed by the treating physician within the existing doctor-patient relationshop, without recording study-specifix personal data. Eligible patients are approached in person by a stdy physician and enrolled only after written informed consent.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wiebke K Kohl-Heckl, Dr.med. contact

004920117425012

w.kohl-heckl@kem-med.com

Germany1 site

  • University Hospital Essen

    Essen, North Rhine-Westphalia

    Andrea Sippel, 0049201723-77374, Andrea.Sippel@uk-essen.de

Other trials in Germany

About this study

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

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

Read the detailed description

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.

Keywords
secondary prevention, prevention, heart attack, lifestyle modification, cardiovascular disease
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.

Study groups in NCT07785921
Study groupRoleWhat they receive
Post-Myocardial Infarction PatientsPatients aged 18 years or older who experienced a myocardical infarction within the past 6 months, treated with percutaneous transluminal coronary angioplasty (PTCA), and recruited during ther routine post-discharge follow-up visit at the Lipidambulanz (lipid outpatient clinic), Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen. Participants complete a one-time set of questionnaires.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Single assessement at study enrollment, baseline

Secondary outcomes (3)

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

    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.

    Measured: Single assessement at study enrollment, baseline

  2. HADS (Hospital Anxiety and Depression Scale)

    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.

    Measured: Single assessement at study enrollment, baseline

  3. KCCQ-23 (Kansas City Cardiomyopathy Questionnaire)

    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.

    Measured: Single assessement at study enrollment, baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07785921
Sponsor's protocol ID
26-12963-BO
Other IDs
Habilitation Scholarship
Acronym
HerzAktiv
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.

    PubMed 10758967

  • Endler NS, Hunt JM. Generalizability of contributions from sources of variance in the S-R inventories of anxiousness. J Pers. 1969 Mar;37(1):1-24. doi: 10.1111/j.1467-6494.1969.tb01728.x. No abstract available.

    PubMed 5778965

  • Chen JJ, Anand SK, Porter PJ. Infectious mononucleosis with thrombocytopenic purpura. Pediatrics. 1968 Feb;41(2):526-8. No abstract available.

    PubMed 5688970

  • Lehmann N, Paul A, Moebus S, Budde T, Dobos GJ, Michalsen A. Effects of lifestyle modification on coronary artery calcium progression and prognostic factors in coronary patients--3-year results of the randomized SAFE-LIFE trial. Atherosclerosis. 2011 Dec;219(2):630-6. doi: 10.1016/j.atherosclerosis.2011.08.050. Epub 2011 Sep 6.

    PubMed 21944697

  • Sanchez Angulo JI, Cuesta Lopez MJ, Zapata Lopez A, Perez Cortes S. [HIV infection and porphyria cutanea tarda]. Enferm Infecc Microbiol Clin. 1997 Aug-Sep;15(7):392-3. No abstract available. Spanish.

    PubMed 9410059

  • Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.

    PubMed 9863851

  • Nguyen XT, Li Y, Wang DD, Whitbourne SB, Houghton SC, Hu FB, Willett WC, Sun YV, Djousse L, Gaziano JM, Cho K, Wilson PW; VA Million Veteran Program. Impact of 8 lifestyle factors on mortality and life expectancy among United States veterans: The Million Veteran Program. Am J Clin Nutr. 2024 Jan;119(1):127-135. doi: 10.1016/j.ajcnut.2023.10.032. Epub 2023 Dec 7.

    PubMed 38065710

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PubMed 15364185

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular (CV) Risk and Heart Attack Patients, run by Kliniken Essen-Mitte at 1 site in Germany.

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 6 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: opening soon, as of the sponsor's last update on 31 Aug 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 Germany. 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 Wiebke K Kohl-Heckl, Dr.med. (004920117425012, w.kohl-heckl@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PIAC (Perception, Intention and Ability to Change) Scale (time frame: Single assessement at study enrollment, baseline). 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 NCT07785921, which also lists 8 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 31 Aug 2026.

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