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New Technologies for Intensive Prevention Programs - NET-IPP

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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

Study details

Coronary Artery Disease

NCT04143646

Herzzentrum Bremen

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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