Intensive Prevention Program After Myocardial Infarction

NCT ID: NCT01896765

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2020-05-31

Brief Summary

It is unknown, if a modern prevention program, including intense nurse-coordinated education sessions, regular telephone contacts and a telephone hotline for 12 months, significantly reduces cardiovascular risk factors, clinical events and quality of life in myocardial infarction patients compared to usual care. Furthermore, actually no data on the additional effects and the feasibility of longterm telemetric care of cardiovascular risk factors exist.

The primary hypothesis to be tested is that an intensive longterm prevention program compared to the standard of medical care, will achieve better risk factor control and consecutively less clinical adverse events in patients after myocardial infarctions. The study endpoints will be evaluated after 12 months and during long-term course (after 24 months = one year after termination of the prevention program).

In a substudy the effects of short reinterventions ("Prevention Boosts") during long-term course are tested (IPP Prevention Boost Study). Patients with at least one insufficiently controlled risk factor at 24-months visit are randomly assigned to a short (2-month) reintervention vs. no reintervention. The effects of the reinterventions on risk factor control are evaluated after 36 months.

A further substudy focusing on young patients <= 45 years of age at time of MI (IPP-Y = IPP in the Young) was added after completion of the pilot IPP study. In this study we focus on the prevention program in young MI-patients. A retrospective analysis of individual genetic risk (assessed by genetic risk scores) in the young patients is included in this substudy.

Conditions

Myocardial Infarction; Prevention Harmful Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intensive prevention program

Standard care with respect to medical and interventional therapy plus intensive prevention program with "study nurse"-coordinated education sessions, regular telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available).

Group Type: EXPERIMENTAL

Intensive Prevention Program

Intervention Type: BEHAVIORAL

"Study nurse"-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available).

Standard medical and interventional therapy

Intervention Type: OTHER

Medical and interventional therapy following the standard of care.

Usual care

Standard care with respect to medical and interventional therapy.

Group Type: OTHER

Standard medical and interventional therapy

Intervention Type: OTHER

Medical and interventional therapy following the standard of care.

Interventions

Intensive Prevention Program

"Study nurse"-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available).

Intervention Type: BEHAVIORAL

Standard medical and interventional therapy

Medical and interventional therapy following the standard of care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Hospitalisation due to myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction)

Exclusion Criteria

i) Hemodynamically significant valvular heart disease (> NYHA class II) or inborn cardiac malformations.

ii) Cardiomyopathy associated with hemodynamic obstruction, pregnancy or myocarditis.

iii) Exercise limitations due to clinical conditions not related to CAD. iv) Any major non-cardiac condition that would adversely effect survival during the duration of the study.

v) Patients unlikely to comply to the study treatment and the follow-up visits. vi) Pregnancy (all pre-menopausal females should have a negative serum pregnancy test).

vii) Inability of cooperation with the protocol, including longterm follow-up. viii) Patient refusal or inability to give informed consent. ix) Refusal of the patient's physician regarding trial participation of the patient.

x) Chronic drug or alcohol abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).

UNKNOWN

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: collaborator

Klinikum Oldenburg gGmbH

OTHER

Sponsor Role: collaborator

Herzzentrum Bremen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herzzentrum Bremen

Bremen, , Germany

Countries

Germany

Other Identifiers

BIHKF-7161

Identifier Type: -

Identifier Source: org_study_id