Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias (HIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Harbinger Medical, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Harbinger Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00562757
First received: November 20, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.


Condition
Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Harbinger ICD Patient (HIP) Study

Resource links provided by NLM:


Further study details as provided by Harbinger Medical, Inc.:

Primary Outcome Measures:
  • Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) [ Time Frame: Up to two years ]

Enrollment: 320
Study Start Date: September 2003
Estimated Study Completion Date: October 2009
Groups/Cohorts
A
Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups

Detailed Description:

Sudden cardiac death (SCD) accounts for half of all deaths from cardiovascular causes, with an annual incidence of 1 to 2 deaths per 1000 population. In the United States this translates to between 300,000 to more than 400,000 deaths annually. Results from numerous large, well designed clinical trials have demonstrated the efficacy of the implantable cardioverter-defibrillator (ICD) for improving survival in patients with ischemic heart disease. However, measures used to risk stratify patients, such as left ventricular ejection fraction do not adequately identify those patients who can most benefit from ICD therapy. As a result, many patients who currently receive an ICD do not use the device. In addition, many more patients who could benefit from ICD therapy are outside of current guidelines and do not have access to this life-saving therapy.

This prospective study was intended to determine how well the Harbinger Wedensky Modulation Index (WMI) technique risk stratifies patients into two groups: those needing antiarrhythmic therapy and those who do not need antiarrhythmic therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post myocardial infarction patients who received an ICD are included. Enrollment is at eight sites - four in the USA and four in three European countries. The enrollment sites are hospitals and teaching institutions.

Criteria

Inclusion Criteria:

  • Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

  • Patients unable to give consent
  • Pacemaker dependant patients
  • Pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562757

Locations
United States, Arizona
Arizona Arrhythmia Consultants
Phoenix, Arizona, United States, 85251
United States, Kansas
Galichia Heart Hospital
Wichita, Kansas, United States, 67220
United States, Massachusetts
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, United States, 02135
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Germany
University of Bonn
Bonn, Germany, D-53105
University of Mannheim
Mannheim, Germany, 68167
Norway
Rikshospital
Oslo, Norway, 0027
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, CH-6000
Sponsors and Collaborators
Harbinger Medical, Inc.
Investigators
Study Director: Harold Hoium, MBA Harbinger Medical, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562757     History of Changes
Other Study ID Numbers: HMI-HIP
Study First Received: November 20, 2007
Last Updated: November 20, 2007
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Norway:National Committee for Medical and Health Research Ethics
Switzerland: Ethikkommission

Keywords provided by Harbinger Medical, Inc.:
Wedensky modulation
Risk stratification
Electrophysiology
Noninvasive
Ischemic heart disease
ICD guidelines
Myocardial infarction

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014