NCT04143646

Brief Summary

In a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). The web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient. In addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (PRS). Patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. The study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
864

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
6mo left

Started May 2020

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress93%
May 2020Oct 2026

First Submitted

Initial submission to the registry

October 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6.5 years

First QC Date

October 23, 2019

Last Update Submit

February 24, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of participants with serious adverse cardiovascular events

    Serious adverse cardiovascular events are death (total and cardiovascular), resuscitations, strokes, myocardial infarctions, coronary revascularizations or hospitalizations due to unstable angina.

    24 months

Secondary Outcomes (6)

  • LDL cholesterol

    24 months

  • Smoking status

    24 months

  • Physical inactivity

    24 months

  • Blood pressure

    24 months

  • Body mass index

    24 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Adherence to preventive medication

    24 months

  • Assessment of quality of life

    24 months

Study Arms (2)

Web-based prevention program

ACTIVE COMPARATOR

Patients after myocardial infarction participate in a 12-months program with telemetric risk factor control, e-learning and E-Mail/App-contacts. In a substudy patients are further randomly assigned to disclosure of genetic risk vs. no disclosure.

Behavioral: Web-based prevention program

Usual Care

NO INTERVENTION

Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.).

Interventions

Web-based prevention programBEHAVIORAL

Telemetric control of risk factors, e-learning, contacts by e-mails/apps. If no response telephone calls. In a substudy evaluation of disclosure of genetic risk.

Web-based prevention program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines
  • Access to internet and consent to participate in a web-based prevention program
  • Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization

You may not qualify if:

  • Patient refusal or inability to give informed consent
  • Hemodynamically significant valvular heart disease
  • Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..)
  • Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis \< 2 years,..)
  • Inability to cooperate with the protocol, including longterm follow-up
  • Chronic drug and alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Bremen

Bremen, 28277, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Bremen Institute for Heart and Circulation Research

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 29, 2019

Study Start

May 1, 2020

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

DE(1)