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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Web-based prevention program
Sponsored by
Herzzentrum Bremen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzzentrum BremenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Web-based prevention program

Usual Care

Arm Description

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.

Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2019
Last Updated
March 2, 2023
Sponsor
Herzzentrum Bremen
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1. Study Identification

Unique Protocol Identification Number
NCT04143646
Brief Title
New Technologies for Intensive Prevention Programs - NET-IPP
Acronym
NET-IPP
Official Title
New Technologies for Intensive Prevention Programs - NET-IPP
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzzentrum Bremen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
864 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Web-based prevention program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.).
Intervention Type
Behavioral
Intervention Name(s)
Web-based prevention program
Intervention Description
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 Outcome Measure Information:
Title
Rate of participants with serious adverse cardiovascular events
Description
Serious adverse cardiovascular events are death (total and cardiovascular), resuscitations, strokes, myocardial infarctions, coronary revascularizations or hospitalizations due to unstable angina.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
LDL cholesterol
Description
LDL cholesterol levels in mg per dl
Time Frame
24 months
Title
Smoking status
Description
Rate of participants who are active smokers in %
Time Frame
24 months
Title
Physical inactivity
Description
Caloric expenditure as assessed by IPAQ (International Physical Activity Questionnaire) in kilocalories per week
Time Frame
24 months
Title
Blood pressure
Description
Systolic and diastolic blood pressure measured in mmHg
Time Frame
24 months
Title
Body mass index
Description
Body mass index in kg/m² (calculated from body weight and height)
Time Frame
24 months
Title
HbA1c
Description
HbA1c levels in %
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Adherence to preventive medication
Description
Rate of patients with lipid-lowering medication, antiplatelets (= aspirine, ticagrelor, prasugrel, clopidogrel)
Time Frame
24 months
Title
Assessment of quality of life
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harm Wienbergen, M.D.
Phone
+49-421-879-1430
Email
harm.wienbergen@klinikum-bremen-ldw.de
Facility Information:
Facility Name
Herzzentrum Bremen
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harm Wienbergen, M.D.
Phone
+49-421-879-1430
Email
harm.wienbergen@klinikum-bremen-ldw.de

12. IPD Sharing Statement

Learn more about this trial

New Technologies for Intensive Prevention Programs - NET-IPP

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