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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Intensive Prevention Program | "Study nurse"-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available). |
| OTHER | Standard medical and interventional therapy | Medical 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.