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Intensive Prevention Program After Myocardial Infarction (IPP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01896765
First Posted: July 11, 2013
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
Information provided by (Responsible Party):
Herzzentrum Bremen
  Purpose

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. A nurse-coordinated program and telemetric prevention will be analyzed.


Condition Intervention
Myocardial Infarction Prevention Harmful Effects Behavioral: Intensive Prevention Program Other: Standard medical and interventional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany

Resource links provided by NLM:


Further study details as provided by Herzzentrum Bremen:

Primary Outcome Measures:
  • Prevention score (point score of cardiovascular risk factors) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Combined endpoint of clinical adverse events [ Time Frame: 12 months ]
  • Adherence to prognostic relevant medication after myocardial infarction [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]

Enrollment: 300
Study Start Date: October 2013
Study Completion Date: July 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive prevention program
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
"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.
Usual care
Standard care with respect to medical and interventional therapy.
Other: Standard medical and interventional therapy
Medical and interventional therapy following the standard of care.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896765


Locations
Germany
Herzzentrum Bremen
Bremen, Germany, 28277
Sponsors and Collaborators
Herzzentrum Bremen
Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
  More Information

Responsible Party: Herzzentrum Bremen
ClinicalTrials.gov Identifier: NCT01896765     History of Changes
Other Study ID Numbers: BIHKF-7161
First Submitted: July 7, 2013
First Posted: July 11, 2013
Last Update Posted: August 10, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases