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Active, Not Recruiting

NCT Number: NCT04143646

New Technologies for Intensive Prevention Programs - NET-IPP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Bremen

Bremen, 28277, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Web-based prevention program

Behavioral

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.

Primary outcomes

  1. Rate of participants with serious adverse cardiovascular events

    Time frame: 24 months

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

Secondary outcomes

  1. LDL cholesterol

    Time frame: 24 months

    LDL cholesterol levels in mg per dl

  2. Smoking status

    Time frame: 24 months

    Rate of participants who are active smokers in %

  3. Physical inactivity

    Time frame: 24 months

    Caloric expenditure as assessed by IPAQ (International Physical Activity Questionnaire) in kilocalories per week

  4. Blood pressure

    Time frame: 24 months

    Systolic and diastolic blood pressure measured in mmHg

  5. Body mass index

    Time frame: 24 months

    Body mass index in kg/m² (calculated from body weight and height)

  6. HbA1c

    Time frame: 24 months

    HbA1c levels in %

Other outcomes

  1. Adherence to preventive medication

    Time frame: 24 months

    Rate of patients with lipid-lowering medication, antiplatelets (= aspirine, ticagrelor, prasugrel, clopidogrel)

  2. Assessment of quality of life

    Time frame: 24 months

    Point score of the European Quality of Life 5 Dimensions (EQ5D) Questionnaire - Visual Analogue Scale (VAS). The Scale ranges from 0 to 100, with 100 indicating the best Quality of Life and 0 indicating the worst Quality of Life

Sponsors and collaborators

Lead sponsor

Herzzentrum Bremen

Other

Registry information

Acronym: NET-IPP

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2019
Registry last updated
Feb 27, 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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