New Technologies for Intensive Prevention Programs - NET-IPP

• Sponsor: Herzzentrum Bremen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04143646
• Collaborator: (none)
• Enrollment: 864
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54
• Patients Per Site Per Month: 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Behavioral: Web-based prevention program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 864 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: New Technologies for Intensive Prevention Programs - NET-IPP
• Actual Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

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.).

Outcome Measures

Primary Outcome Measures

1. 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

1. LDL cholesterol [24 months]

   LDL cholesterol levels in mg per dl

2. Smoking status [24 months]

   Rate of participants who are active smokers in %

3. Physical inactivity [24 months]

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

4. Blood pressure [24 months]

   Systolic and diastolic blood pressure measured in mmHg

5. Body mass index [24 months]

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

6. HbA1c [24 months]

   HbA1c levels in %

Other Outcome Measures

1. Adherence to preventive medication [24 months]

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

2. Assessment of quality of life [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herzzentrum Bremen	Bremen		Germany	28277

Sponsors and Collaborators

• Herzzentrum Bremen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Harm Wienbergen, Head of the Bremen Institute for Heart and Circulation Research, Herzzentrum Bremen
• ClinicalTrials.gov Identifier: NCT04143646
• Other Study ID Numbers: BIHKF 3
• First Posted: Oct 29, 2019
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Aug 25, 2021