Ventricular TachycardiaABCDNCT00583297
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
An observational study of Ventricular Tachycardia and Cardiovascular Diseases, run by CardioDx at 1 site in United States.
Trial summary
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 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: The target population for the ABCD genetic sub-study includes all living individuals currently enrolled in the ABCD trial (total study enrollment=629; 566 analyzed in the trial) Participants of the ABCD trial underwent TWA and EPS testing to determine their risk for ventricular arrhythmia and most have received an implantable cardioverter defibrillator (ICD). The ABCD trial collected extensive longitudinal clinical data including medical and medication histories, incidence of ventricular arrhythmias, defibrillator shocks, other cardiovascular events, and mortality.
Who may be able to join
- Subjects previously enrolled in the ABCD trial sponsored by St. Jude Medical (ClinicalTrials.gov Identifier NCT00187291)
- patients with ischemic heart disease
- left ventricular ejection fraction (LVEF) < 40%
- non-sustained ventricular tachycardia
Who cannot join
- Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this same population.
Read the detailed description
The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans (TWA) test, measured non-invasively during exercise, is equivalent to therapy directed by an electrophysiological study (EPS) in predicting spontaneous ventricular tachyarrhythmic events (VTEs) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia (NSVT). In the absence of any previous life-threatening ventricular arrhythmia (i.e., for primary prevention), ICD implantation is currently indicated in patients with ischemic heart disease, left ventricular dysfunction, asymptomatic non-sustained ventricular tachycardia, and a positive EPS. The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death (SCD) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia.
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Keywords
- Arrhythmia, Heart Failure, T-wave Alternans, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CVD, Precision Medicine, Sudden Cardiac Death, Electrophysiology Study, Cardiovascular Disease, ICD, EPS, SCD, TWA
- Medical subject headings
- Tachycardia, Ventricular, Cardiovascular Diseases, Arrhythmias, Cardiac, Heart Failure, Death, Sudden, Cardiac
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 |
|---|---|---|
| ABCD Subjects | The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype and Pre-implant T-wave alternans status.
Genotype and Pre-implant T-wave alternans status.
Measured: two years as per original ABCD trial
Secondary outcomes (1)
Genotype and occurrence of appropriate cardioversion
Genotype and occurrence of appropriate cardioversion for ventricular tachycardia or ventricular fibrillation
Measured: two years per original ABCD trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy J Sehnert, MD, Study director, CardioDx, Inc.Elizabeth Kaufman, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583297
- Sponsor's protocol ID
- CDX_000001
- Other IDs
- ABCD
- Acronym
- ABCD
- Status last verified
- Oct 2017
- First submitted
- 20 Dec 2007
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilson LD, Wan X, Rosenbaum DS. Cellular alternans: a mechanism linking calcium cycling proteins to cardiac arrhythmogenesis. Ann N Y Acad Sci. 2006 Oct;1080:216-34. doi: 10.1196/annals.1380.018.
PubMed 17132786Bloomfield DM, Bigger JT, Steinman RC, Namerow PB, Parides MK, Curtis AB, Kaufman ES, Davidenko JM, Shinn TS, Fontaine JM. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006 Jan 17;47(2):456-63. doi: 10.1016/j.jacc.2005.11.026. Epub 2005 Dec 15.
PubMed 16412877
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT00583297
- Acronym / sponsor ID
- ABCD / CDX_000001
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Keywords
- Arrhythmia, Heart Failure, T-wave Alternans, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Corus CAD, ASGES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Dec 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 ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this same population.
Detailed description
The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans (TWA) test, measured non-invasively during exercise, is equivalent to therapy directed by an electrophysiological study (EPS) in predicting spontaneous ventricular tachyarrhythmic events (VTEs) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia (NSVT). In the absence of any previous life-threatening ventricular arrhythmia (i.e., for primary prevention), ICD implantation is currently indicated in patients with ischemic heart disease, left ventricular dysfunction, asymptomatic non-sustained ventricular tachycardia, and a positive EPS. The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death (SCD) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABCD Subjects | – | –The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for the ABCD genetic sub-study includes all living individuals currently enrolled in the ABCD trial (total study enrollment=629; 566 analyzed in the trial) Participants of the ABCD trial underwent TWA and EPS testing to determine their risk for ventricular arrhythmia and most have received an implantable cardioverter defibrillator (ICD). The ABCD trial collected extensive longitudinal clinical data including medical and medication histories, incidence of ventricular arrhythmias, defibrillator shocks, other cardiovascular events, and mortality.
Key inclusion criteria (4 listed)
- Subjects previously enrolled in the ABCD trial sponsored by St. Jude Medical (ClinicalTrials.gov Identifier NCT00187291)
- patients with ischemic heart disease
- left ventricular ejection fraction (LVEF) < 40%
- non-sustained ventricular tachycardia
Key exclusion criteria (1 listed)
- Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.
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
Genotype and Pre-implant T-wave alternans status.
Time frame: two years as per original ABCD trial
Genotype and Pre-implant T-wave alternans status.
1 secondary outcome
Genotype and occurrence of appropriate cardioversion
Time frame: two years per original ABCD trial
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 22 Feb 2018.
- Background: PubMed 17132786Wilson LD, Wan X, Rosenbaum DS. Cellular alternans: a mechanism linking calcium cycling proteins to cardiac arrhythmogenesis. Ann N Y Acad Sci. 2006 Oct;1080:216-34. doi: 10.1196/annals.1380.018.
- Background: PubMed 16412877Bloomfield DM, Bigger JT, Steinman RC, Namerow PB, Parides MK, Curtis AB, Kaufman ES, Davidenko JM, Shinn TS, Fontaine JM. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006 Jan 17;47(2):456-63. doi: 10.1016/j.jacc.2005.11.026. Epub 2005 Dec 15.
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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.
Amy J Sehnert, MD study director
CardioDx, Inc.
Elizabeth Kaufman, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Cardiovascular Diseases, run by CardioDx at 1 site in United States.
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 4 inclusion and 1 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Genotype and Pre-implant T-wave alternans status. (time frame: two years as per original ABCD trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583297, which also lists 2 linked publications.
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 Feb 2018.