Intensive Prevention Program After Myocardial Infarction

Myocardial Infarction Clinical Trial

— IPP  

Official title:

Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896765
• Other study ID #: BIHKF-7161
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2020

Study information

• Verified date: June 2020
• Source: Herzzentrum Bremen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Prevention Harmful Effects

Intervention

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.

Locations

Country	Name	City	State
Germany	Herzzentrum Bremen	Bremen

Sponsors (4)

Lead Sponsor	Collaborator
Herzzentrum Bremen	Klinikum Oldenburg gGmbH, Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS)., University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention score (point score of cardiovascular risk factors)		24 months
Primary	Prevention success	Improvement of one of the risk factors LDL-cholesterol, physical inactivity, smoking without deterioration of another (primary endpoint for IPP-Y = substudy on young MI-patients <= 45 years that was added after completion of the pilot study)	24 months
Secondary	Combined endpoint of clinical adverse events		24 months
Secondary	Adherence to prognostic relevant medication after myocardial infarction		24 months