Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01896765
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2013-07-07
Brief Title:
Intensive Prevention Program After Myocardial Infarction
Sponsor:
Herzzentrum Bremen
Organization:
Herzzentrum Bremen
Study Overview
Official Title:
Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPP
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None