Sudden Cardiac DeathHIPNCT00562757
Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias
An observational study of Sudden Cardiac Death, run by Harbinger Medical, Inc. at 8 sites in 4 countries.
Trial summary
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 320 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2003to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Post myocardial infarction patients receiving ICD therapy
Who cannot join
- Patients unable to give consent
- Pacemaker dependant patients
- Pregnant women
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, 02135
Arizona Arrhythmia Consultants
Phoenix, Arizona, 85251
Mayo Clinic
Rochester, Minnesota, 55902
Galichia Heart Hospital
Wichita, Kansas, 67220
Germany2 sites
University of Bonn
Bonn, D-53105
University of Mannheim
Mannheim, 68167
About this study
Official title: The Harbinger ICD Patient (HIP) Study
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
Read the 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.
- Conditions
- Sudden Cardiac Death
- Keywords
- Wedensky modulation, Risk stratification, Electrophysiology, Noninvasive, Ischemic heart disease, ICD guidelines, Myocardial infarction
- Medical subject headings
- Death, Sudden, Cardiac, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review)
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startSep 2003
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbinger Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Harold Hoium, MBA, Study director, Harbinger Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562757
- Sponsor's protocol ID
- HMI-HIP
- Acronym
- HIP
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Harbinger ICD Patient (HIP) Study
- ClinicalTrials.gov ID
- NCT00562757
- Acronym / sponsor ID
- HIP / HMI-HIP
- Conditions
- Sudden Cardiac Death
- Keywords
- Wedensky modulation, Risk stratification, Electrophysiology, Noninvasive, Ischemic heart disease, ICD guidelines, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Harbinger Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Oct 2009 (estimated)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Post myocardial infarction patients receiving ICD therapy
Key exclusion criteria (3 listed)
- Patients unable to give consent
- Pacemaker dependant patients
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review)
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Hoium, MBA study director
Harbinger Medical, Inc.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Harbinger Medical, Inc. at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Norway, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) (time frame: Up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2007.