NCT07785921

Brief 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 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

secondary preventionpreventionheart attacklifestyle modificationcardiovascular disease

Outcome Measures

Primary Outcomes (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.

    Single assessement at study enrollment

Secondary Outcomes (3)

  • SF-36 (Short-form 36 Health Survey)

    Single assessement at study enrollment.

  • HADS (Hospital Anxiety and Depression Scale)

    Single assessement at study enrollment.

  • KCCQ-23 (Kansas City Cardiomyopathy Questionnaire)

    Single assessement at study enrollment.

Study Arms (1)

Post-Myocardial Infarction Patients

Patients 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Location

Related Publications (8)

  • 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.

    PMID: 10758967BACKGROUND
  • 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.

    PMID: 5778965BACKGROUND
  • Chen JJ, Anand SK, Porter PJ. Infectious mononucleosis with thrombocytopenic purpura. Pediatrics. 1968 Feb;41(2):526-8. No abstract available.

    PMID: 5688970BACKGROUND
  • 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.

    PMID: 21944697BACKGROUND
  • 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.

    PMID: 9410059BACKGROUND
  • 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.

    PMID: 9863851BACKGROUND
  • 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.

    PMID: 38065710BACKGROUND
  • 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.

    PMID: 15364185BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Wiebke Kohl, Dr.med

    Center for Integrative Medicine and Planetary Health, University Hospital Essen

    PRINCIPAL INVESTIGATOR
  • Gustav Dobos, Prof. Dr. med.

    Center for Integrative Medicine and Planetary Health, University Hospital Essen

    STUDY DIRECTOR

Central Study Contacts

Wiebke K Kohl-Heckl, Dr.med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations