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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

July 7, 2013
July 11, 2013
October 2013
July 2016   (final data collection date for primary outcome measure)
Prevention score (point score of cardiovascular risk factors) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01896765 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intensive Prevention Program After Myocardial Infarction
Intensive Longterm Prevention Program After Myocardial Infarction in Northwest Germany

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Myocardial Infarction.
  • Prevention Harmful Effects.
  • 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.
  • 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).
    Interventions:
    • Behavioral: Intensive Prevention Program
    • Other: Standard medical and interventional therapy
  • Usual care
    Standard care with respect to medical and interventional therapy.
    Intervention: Other: Standard medical and interventional therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2016
July 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
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
Germany
 
NCT01896765
BIHKF-7161
Yes
Herzzentrum Bremen
Herzzentrum Bremen
Oldenburger Forschungs- und Entwicklungsinstitut für Informatik (OFFIS).
Not Provided
Herzzentrum Bremen
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP