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Completed

NCT Number: NCT01896765

Intensive Prevention Program After Myocardial Infarction

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Bremen

Bremen, 28277, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Standard medical and interventional therapy

Other

Medical and interventional therapy following the standard of care.

Primary outcomes

  1. Prevention score (point score of cardiovascular risk factors)

    Time frame: 24 months

  2. Prevention success

    Time frame: 24 months

    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)

Secondary outcomes

  1. Combined endpoint of clinical adverse events

    Time frame: 24 months

  2. Adherence to prognostic relevant medication after myocardial infarction

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Herzzentrum Bremen

Other

Collaborators

  • Klinikum Oldenburg gGmbH
  • Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
  • University of Luebeck

Registry information

Official study title

Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany

Acronym: IPP

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2013
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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