CardiomyopathiesNCT00926159
Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death
An observational study of Cardiomyopathies, run by University of Minnesota Physicians Heart at Fairview.
Trial summary
Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of sudden cardiac death from a life-threatening heart rhythm abnormality is a standard recommendation for patients with ejection fractions (EFs) of 35% or less. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies
- How many people
- 549 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Nov 2010
- 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: Minnesota Heart Clinic Patients with an ejection fraction of 35% or less as identified from cardiac echocardiogram and/or cardiac nuclear scan.
Who may be able to join
- Age 18 years or older
- Ejection fraction of 35% or less by echocardiogram and/or cardiac nuclear scan
Who cannot join
- Age less than 18 years
- Patients currently enrolled in a clinical trial that would be impacted by receipt of an ICD
- Pregnant women
About this study
Official title: "Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death"
Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of sudden cardiac death from a life-threatening heart rhythm abnormality is a standard recommendation for patients with ejection fractions (EFs) of 35% or less. The main purpose of the trial is to determine why patients who are receiving care at a community-based cardiology program and are known to have a low ejection fraction (EF) measurement of 35% or less per echocardiogram and/or cardiac nuclear scan testing are not being approached for ICD (implantable cardioverter defibrillator) implant. Additionally, other secondary purposes of the trial are: 1) to determine if these patients are or are not receiving recommendation from their provider to undergo prophylactic ICD implant 2) identify the reasons providers are not recommending ICD implant for their patients with reduced EFs 3) determine reasons patients recommended for ICD implant by their provider elect not to have the implant.
Read the detailed description
The implantable cardioverter defibrillator (ICD) for patients at high risk of sudden cardiac death (primary prevention) has become an accepted therapy after multiple randomized trials demonstrated the benefit consistently. After years of extensive evaluation of the trial data, Center for Medicare and Medicaid Services(CMS) has approved the national registry that is endorsed by the American College of Cardiology and Heart Rhythm Society. Thus, ICD implantation for primary prevention of sudden cardiac death is one of the most intensively evaluated, strictly regulated and closely monitored therapies.
Since the approval of expanded coverage for primary prevention by CMS along with the requirement for registry participation in early 2005, the ICD implant volume did not show an apparent increase as expected by many. Instead, a flat growth of ICD sales has been observed over the last 2 years. Several explanations have been offered by various sources. Some attribute the slow growth to the loss of confidence among the referring physicians, patients, and family members as the result of the multiple industry recalls. Others claim that only a small portion of the eligible candidates receive ICD therapy because of poor awareness of the ICD benefit among the referring physicians and the public (the Cambridge Heart Commercial). However, the Medtronic campaign to promote public awareness has had little impact on the volume of ICD implants. Another group of people suspect that the cardiologists have not paid enough attention to the patients' candidacy for ICD therapy because they tend to focus on the patients' ongoing symptoms not proactive prevention. Thus,an active screening program may identify a significant number of patients who will benefit from ICD therapy. However, there has been no comprehensive study that has evaluated the impact of active screening on the ICD implant volume, the percentage of eligible ICD patients without ICDs and the reasons for not receiving ICDs.
Majority of ICD implants in the United States are currently performed in the community-based cardiology programs. Thus a proactive program to identify ICD candidates in a community-based program may provide a good assessment on the unrealized potential benefit of ICDs for primary prevention of sudden cardiac death.
- Conditions
- Cardiomyopathies
- Keywords
- Cardiomyopathies
- Medical subject headings
- Cardiomyopathies
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 |
|---|---|---|
| ICD eligible | Patients with Ejection Fraction (EF) of 35% or less as determined by cardiac echocardiogram or cardiac nuclear scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Heart Clinic Provider progress note from the first office visit after the cardiac echocardiogram or nuclear scan that qualified the patient for inclusion in the trial will be reviewed for documentation of discussion regarding ICD implant.
Measured: First scheduled office visit with a Minnesota Heart Clinic Provider scheduled and conducted after the study qualifying cardiac echocardiogram or cardiac nuclear scan.
Secondary outcomes (1)
A questionnaire will be issued/reviewed after completed by Providers to obtain reason(s) for not recommending ICD implant.
Measured: Questionnaire will be issued after review of progress note identifies no documentation regarding possible ICD implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies 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 only
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota Physicians Heart at Fairview
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Investigators
- Huagui Li, MD, PhD, Principal investigator, University of Minnesota Physicians, Minnesota Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926159
- Sponsor's protocol ID
- Version # 3, December 4, 2009
- Status last verified
- Jan 2011
- First submitted
- 22 Jun 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death"
- ClinicalTrials.gov ID
- NCT00926159
- Acronym / sponsor ID
- Version # 3, December 4, 2009
- Conditions
- Cardiomyopathies
- Keywords
- Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- University of Minnesota Physicians Heart at FairviewUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Jun 2009 (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.
Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of sudden cardiac death from a life-threatening heart rhythm abnormality is a standard recommendation for patients with ejection fractions (EFs) of 35% or less. The main purpose of the trial is to determine why patients who are receiving care at a community-based cardiology program and are known to have a low ejection fraction (EF) measurement of 35% or less per echocardiogram and/or cardiac nuclear scan testing are not being approached for ICD (implantable cardioverter defibrillator) implant. Additionally, other secondary purposes of the trial are: 1) to determine if these patients are or are not receiving recommendation from their provider to undergo prophylactic ICD implant 2) identify the reasons providers are not recommending ICD implant for their patients with reduced EFs 3) determine reasons patients recommended for ICD implant by their provider elect not to have the implant.
Detailed description
The implantable cardioverter defibrillator (ICD) for patients at high risk of sudden cardiac death (primary prevention) has become an accepted therapy after multiple randomized trials demonstrated the benefit consistently. After years of extensive evaluation of the trial data, Center for Medicare and Medicaid Services(CMS) has approved the national registry that is endorsed by the American College of Cardiology and Heart Rhythm Society. Thus, ICD implantation for primary prevention of sudden cardiac death is one of the most intensively evaluated, strictly regulated and closely monitored therapies.
Since the approval of expanded coverage for primary prevention by CMS along with the requirement for registry participation in early 2005, the ICD implant volume did not show an apparent increase as expected by many. Instead, a flat growth of ICD sales has been observed over the last 2 years. Several explanations have been offered by various sources. Some attribute the slow growth to the loss of confidence among the referring physicians, patients, and family members as the result of the multiple industry recalls. Others claim that only a small portion of the eligible candidates receive ICD therapy because of poor awareness of the ICD benefit among the referring physicians and the public (the Cambridge Heart Commercial). However, the Medtronic campaign to promote public awareness has had little impact on the volume of ICD implants. Another group of people suspect that the cardiologists have not paid enough attention to the patients' candidacy for ICD therapy because they tend to focus on the patients' ongoing symptoms not proactive prevention. Thus,an active screening program may identify a significant number of patients who will benefit from ICD therapy. However, there has been no comprehensive study that has evaluated the impact of active screening on the ICD implant volume, the percentage of eligible ICD patients without ICDs and the reasons for not receiving ICDs.
Majority of ICD implants in the United States are currently performed in the community-based cardiology programs. Thus a proactive program to identify ICD candidates in a community-based program may provide a good assessment on the unrealized potential benefit of ICDs for primary prevention of sudden cardiac death.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD eligible | – | –Patients with Ejection Fraction (EF) of 35% or less as determined by cardiac echocardiogram or cardiac nuclear scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Minnesota Heart Clinic Patients with an ejection fraction of 35% or less as identified from cardiac echocardiogram and/or cardiac nuclear scan.
Key inclusion criteria (2 listed)
- Age 18 years or older
- Ejection fraction of 35% or less by echocardiogram and/or cardiac nuclear scan
Key exclusion criteria (3 listed)
- Age less than 18 years
- Patients currently enrolled in a clinical trial that would be impacted by receipt of an ICD
- 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
Minnesota Heart Clinic Provider progress note from the first office visit after the cardiac echocardiogram or nuclear scan that qualified the patient for inclusion in the trial will be reviewed for documentation of discussion regarding ICD implant.
Time frame: First scheduled office visit with a Minnesota Heart Clinic Provider scheduled and conducted after the study qualifying cardiac echocardiogram or cardiac nuclear scan.
1 secondary outcome
A questionnaire will be issued/reviewed after completed by Providers to obtain reason(s) for not recommending ICD implant.
Time frame: Questionnaire will be issued after review of progress note identifies no documentation regarding possible ICD implant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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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.
Huagui Li, MD, PhD principal investigator
University of Minnesota Physicians, Minnesota Heart Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by University of Minnesota Physicians Heart at Fairview.
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 2 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: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Minnesota Heart Clinic Provider progress note from the first office visit after the cardiac echocardiogram or nuclear scan that qualified the patient for inclusion in the trial will be reviewed for documentation of discussion regarding ICD implant. (time frame: First scheduled office visit with a Minnesota Heart Clinic Provider scheduled and conducted after the study qualifying cardiac echocardiogram or cardiac nuclear scan.). 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 4 Aug 2011.