New Technologies for Intensive Prevention Programs - NET-IPP (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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Web-based prevention program

• Study Type: Interventional
• Enrollment (Anticipated): 864
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harm Wienbergen, M.D.; Phone Number: +49-421-879-1430; Email: harm.wienbergen@klinikum-bremen-ldw.de

Study Locations

• Germany
  • Bremen, Germany, 28277
    • Recruiting
    • Herzzentrum Bremen
    • Contact: Harm Wienbergen, M.D.; Phone Number: +49-421-879-1430; Email: harm.wienbergen@klinikum-bremen-ldw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
No Intervention: Usual Care; Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to preventive medication	Rate of patients with lipid-lowering medication, antiplatelets (= aspirine, ticagrelor, prasugrel, clopidogrel)	24 months
Assessment of quality of life	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	24 months

Collaborators and Investigators

• Sponsor: Herzzentrum Bremen

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BIHKF 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No