New Technologies for Intensive Prevention Programs - NET-IPP

Coronary Artery Disease Clinical Trial

— NET-IPP  

Official title:

New Technologies for Intensive Prevention Programs - NET-IPP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143646
• Other study ID #: BIHKF 3
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2023
• Source: Herzzentrum Bremen
• Contact: Harm Wienbergen, M.D.
• Phone: +49-421-879-1430
• Email: harm.wienbergen[@]klinikum-bremen-ldw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 864
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	Herzzentrum Bremen	Bremen

Sponsors (1)

Lead Sponsor	Collaborator
Herzzentrum Bremen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to preventive medication	Rate of patients with lipid-lowering medication, antiplatelets (= aspirine, ticagrelor, prasugrel, clopidogrel)	24 months
Other	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
Primary	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	LDL cholesterol	LDL cholesterol levels in mg per dl	24 months
Secondary	Smoking status	Rate of participants who are active smokers in %	24 months
Secondary	Physical inactivity	Caloric expenditure as assessed by IPAQ (International Physical Activity Questionnaire) in kilocalories per week	24 months
Secondary	Blood pressure	Systolic and diastolic blood pressure measured in mmHg	24 months
Secondary	Body mass index	Body mass index in kg/m² (calculated from body weight and height)	24 months
Secondary	HbA1c	HbA1c levels in %	24 months