New Technologies for Intensive Prevention Programs - NET-IPP

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Web-based prevention program

• Registration Number: NCT04143646
• Lead Sponsor: Herzzentrum Bremen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2020-05-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 864

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based prevention program	Web-based prevention program	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Physical inactivity	24 months	Caloric expenditure as assessed by IPAQ (International Physical Activity Questionnaire) in kilocalories per week
LDL cholesterol	24 months	LDL cholesterol levels in mg per dl
HbA1c	24 months	HbA1c levels in %
Blood pressure	24 months	Systolic and diastolic blood pressure measured in mmHg
Body mass index	24 months	Body mass index in kg/m² (calculated from body weight and height)
Smoking status	24 months	Rate of participants who are active smokers in %

Trial Locations

Locations (1)

Herzzentrum Bremen; 🇩🇪 Bremen, Germany