Intensive Prevention Program After Myocardial Infarction (IPP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Herzzentrum Bremen
Sponsor:
Collaborator:
Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
Information provided by (Responsible Party):
Herzzentrum Bremen
ClinicalTrials.gov Identifier:
NCT01896765
First received: July 7, 2013
Last updated: July 11, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined endpoint of clinical adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adherence to prognostic relevant medication after myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896765

Contacts
Contact: Harm Wienbergen, MD 01149 421 879 4059 harm.wienbergen@klinikum-bremen-ldw.de
Contact: Rainer Hambrecht, MD 01149 421 879 1430 rainer.hambrecht@klinikum-bremen-ldw.de

Locations
Germany
Herzzentrum Bremen Not yet recruiting
Bremen, Germany, 28277
Contact: Harm Wienbergen, MD    01149 421 879 4059    harm.wienbergen@klinikum-bremen-ldw.de   
Principal Investigator: Harm Wienbergen, MD         
Sponsors and Collaborators
Herzzentrum Bremen
Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
  More Information

No publications provided

Responsible Party: Herzzentrum Bremen
ClinicalTrials.gov Identifier: NCT01896765     History of Changes
Other Study ID Numbers: BIHKF-7161
Study First Received: July 7, 2013
Last Updated: July 11, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 29, 2014