Ireland
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Active, not recruiting Not applicable

New Technologies for Intensive Prevention Programs - NET-IPP

NCT04143646 · tracked via the Priya Life Science Germany tracker
Sponsor
Herzzentrum Bremen
Phase
Not applicable
Started
2020-05-01
Last updated
2026-02-27

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Web-based prevention program

Web-based prevention program: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines 2. Access to internet and consent to participate in a web-based prevention program 3. Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization Exclusion Criteria: 1. Patient refusal or inability to give informed consent 2. Hemodynamically significant valvular heart disease 3. Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..) 4. Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis \< 2 years,..) 5. Inability to cooperate with the protocol, including longterm follow-up 6. Chronic drug and alcohol abuse

Primary outcome measure(s)

  • Rate of participants with serious adverse cardiovascular events — 24 months
    Serious adverse cardiovascular events are death (total and cardiovascular), resuscitations, strokes, myocardial infarctions, coronary revascularizations or hospitalizations due to unstable angina.

Trial sites (1)

FacilityCityRegionStatus
Herzzentrum Bremen Bremen Germany

More Herzzentrum Bremen trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04143646 on ClinicalTrials.gov ↗ ← All trials in Germany