Intensive Prevention Program After Myocardial Infarction

NCT01896765 | Completed DMC

• 1 other identifier: BIHKF-7161
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Prevention score (point score of cardiovascular risk factors)

  24 months

• 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 Outcomes (2)

• Combined endpoint of clinical adverse events

  24 months

• Adherence to prognostic relevant medication after myocardial infarction

  24 months

Study Arms (2)

Intensive prevention program

EXPERIMENTAL

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).

Behavioral: Intensive Prevention Program; Other: Standard medical and interventional therapy

Usual care

OTHER

Standard care with respect to medical and interventional therapy.

Other: Standard medical and interventional therapy

Interventions

Intensive Prevention Program BEHAVIORAL

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

Intensive prevention program

Standard medical and interventional therapy OTHER

Medical and interventional therapy following the standard of care.

Intensive prevention program; Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herzzentrum Bremen: lead
• Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).: collaborator
• University of Luebeck: collaborator
• Klinikum Oldenburg gGmbH: collaborator

Study Sites (1)

Herzzentrum Bremen

Bremen, 28277, Germany

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2013
• First Posted: July 11, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

DE (1)