Ischemic CardiomyopathyPhase 3NCT00187291
Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)
A Phase 3 study testing T-Wave Alternans test in people with Ischemic Cardiomyopathy and LV Dysfunction, run by Abbott Medical Devices.
Trial summary
The ABCD clinical study is 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy, LV Dysfunction
- What is being tested?
- T-Wave Alternans test
- Type of treatment
- Medical device
- How many people
- 618 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Jul 2006
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study:
- Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease
- LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment.
- Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial.
- The patient is 18 years of age or older.
- In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm.
- The patient has signed the latest IRB approved informed consent form.
Who cannot join
- Patients meeting any of the following exclusion criteria will not be eligible for enrollment:
- The patient is unable to give informed consent.
- The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication).
- The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial.
- The patient has unstable coronary artery disease.
- The patient has contraindications to ICD implantation.
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- A submaximal exercise test is contraindicated.
- The patient has persistent atrial fibrillation or flutter.
- The patient is less than 28 days post MI, post CABG, or post coronary angioplasty.
- The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1.
- The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment.
- The patient is on any class 1 or 3 antiarrhythmic drug.
- The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the eligibility of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini.
- The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation.
- The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia.
- The patient has a life expectancy of less than one year from any cause.
- The patient has a positive pregnancy test.
- The patient is not geographically stable or is unable to comply with the follow up schedule.
About this study
Official title: Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study is 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. Patients undergo both the TWA test and EP study and receive an Implantable Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events and total mortality are to be evaluated over the duration of the study.
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.
This is a prospective, multi-center study to demonstrate the following:
PRIMARY HYPOTHESIS: a TWA test directed therapy is equivalent to EPS directed therapy in predicting VTEs in patients with ischemic heart disease, LVEF less than 0.40, and asymptomatic non-sustained ventricular tachycardia. The study will determine whether the positive predictive value of TWA test directed therapy is equivalent to the positive predictive value of EPS directed therapy. The study will also determine whether the negative predictive value of TWA test directed therapy is equivalent to the negative predictive value of EPS directed therapy. The positive groups under TWA test directed therapy will be compared with the positive groups under EPS directed therapy, and the negative groups under TWA directed therapy will be compared with the negative groups under EPS directed therapy. SECONDARY HYPOTHESIS: The study will determine whether the positive predictive value of a TWA test (not including indeterminates) is equivalent to the positive predictive value of an EPS in predicting future VTEs. The study will also determine whether the negative predictive value of a TWA test (not including indeterminates) is equivalent to the negative predictive value of an EPS in predicting future VTEs. The TWA test positive groups will be compared with the EPS positive groups, and the TWA test negative groups will be compared with the EPS negative groups. The secondary hypothesis will also be tested against the primary endpoint defined above.
- Conditions
- Ischemic Cardiomyopathy, LV Dysfunction
- Being tested
- T-Wave Alternans test
- Keywords
- T-Wave Alternans, ICD, Primary Prevention
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Wave Alternans testDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular tachyarrhythmic events
Measured: 12 months
Secondary outcomes (2)
Total Mortality
Measured: 12 months
Ventricular tachyarrhythmic events below rate detection of the ICD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 618 participants
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge Heart Inc., MetroHealth Medical Center
- Investigators
- David Rosenbaum, MD, Study chair, MetroHealth Medical CenterOtto Costantini, MD, Study chair, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187291
- Sponsor's protocol ID
- G010050
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Costantini O, Hohnloser SH, Kirk MM, Lerman BB, Baker JH 2nd, Sethuraman B, Dettmer MM, Rosenbaum DS; ABCD Trial Investigators. The ABCD (Alternans Before Cardioverter Defibrillator) Trial: strategies using T-wave alternans to improve efficiency of sudden cardiac death prevention. J Am Coll Cardiol. 2009 Feb 10;53(6):471-9. doi: 10.1016/j.jacc.2008.08.077.
PubMed 19195603
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternans Before Cardioverter Defibrillator (ABCD) Trial
- ClinicalTrials.gov ID
- NCT00187291
- Acronym / sponsor ID
- G010050
- Conditions
- Ischemic Cardiomyopathy, LV Dysfunction
- Keywords
- T-Wave Alternans, ICD, Primary Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge Heart Inc., MetroHealth Medical Center
- Study start
- Apr 2001
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Sep 2005 (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 is 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. Patients undergo both the TWA test and EP study and receive an Implantable Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events and total mortality are to be evaluated over the duration of the study.
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.
This is a prospective, multi-center study to demonstrate the following:
PRIMARY HYPOTHESIS: a TWA test directed therapy is equivalent to EPS directed therapy in predicting VTEs in patients with ischemic heart disease, LVEF less than 0.40, and asymptomatic non-sustained ventricular tachycardia. The study will determine whether the positive predictive value of TWA test directed therapy is equivalent to the positive predictive value of EPS directed therapy. The study will also determine whether the negative predictive value of TWA test directed therapy is equivalent to the negative predictive value of EPS directed therapy. The positive groups under TWA test directed therapy will be compared with the positive groups under EPS directed therapy, and the negative groups under TWA directed therapy will be compared with the negative groups under EPS directed therapy. SECONDARY HYPOTHESIS: The study will determine whether the positive predictive value of a TWA test (not including indeterminates) is equivalent to the positive predictive value of an EPS in predicting future VTEs. The study will also determine whether the negative predictive value of a TWA test (not including indeterminates) is equivalent to the negative predictive value of an EPS in predicting future VTEs. The TWA test positive groups will be compared with the EPS positive groups, and the TWA test negative groups will be compared with the EPS negative groups. The secondary hypothesis will also be tested against the primary endpoint defined above.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study:
- Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease
- LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment.
- Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial.
- The patient is 18 years of age or older.
Key exclusion criteria (18 listed)
- Patients meeting any of the following exclusion criteria will not be eligible for enrollment:
- The patient is unable to give informed consent.
- The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication).
- The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial.
- The patient has unstable coronary artery disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Wave Alternans test | Device | – |
Primary outcome
Ventricular tachyarrhythmic events
Time frame: 12 months
2 secondary outcomes
Total Mortality
Time frame: 12 months
Ventricular tachyarrhythmic events below rate detection of the ICD
Time frame: 12 months
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 13 Jul 2023.
- Derived from this study: PubMed 19195603Costantini O, Hohnloser SH, Kirk MM, Lerman BB, Baker JH 2nd, Sethuraman B, Dettmer MM, Rosenbaum DS; ABCD Trial Investigators. The ABCD (Alternans Before Cardioverter Defibrillator) Trial: strategies using T-wave alternans to improve efficiency of sudden cardiac death prevention. J Am Coll Cardiol. 2009 Feb 10;53(6):471-9. doi: 10.1016/j.jacc.2008.08.077.
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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.
David Rosenbaum, MD study chair
MetroHealth Medical Center
Otto Costantini, MD study chair
MetroHealth Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T-Wave Alternans test in people with Ischemic Cardiomyopathy and LV Dysfunction, run by Abbott Medical Devices.
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 7 inclusion and 18 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 13 Jul 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ventricular tachyarrhythmic events (time frame: 12 months). 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 NCT00187291, which also lists 1 linked publication.
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 13 Jul 2023.