Clinical Trials Directory

Trials / Completed

CompletedNCT01896765

Intensive Prevention Program After Myocardial Infarction

Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (actual)
Sponsor
Herzzentrum Bremen · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALIntensive Prevention Program"Study nurse"-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available).
OTHERStandard medical and interventional therapyMedical and interventional therapy following the standard of care.

Timeline

Start date
2013-10-01
Primary completion
2020-03-01
Completion
2020-05-01
First posted
2013-07-11
Last updated
2020-06-23

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01896765. Inclusion in this directory is not an endorsement.