Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)

NCT00187291 | Completed Phase 3 DMC

• 1 other identifier: G010050
• Study Type: interventional
• Target: 618
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Ischemic Cardiomyopathy; LV Dysfunction

Keywords

T-Wave Alternans; ICD; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• Ventricular tachyarrhythmic events

  12 months

Secondary Outcomes (2)

• Total Mortality

  12 months

• Ventricular tachyarrhythmic events below rate detection of the ICD

  12 months

Interventions

T-Wave Alternans test DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Cambridge Heart Inc.: collaborator
• MetroHealth Medical Center: collaborator

Related Publications (1)

• 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.

  PMID: 19195603 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• David Rosenbaum, MD

  MetroHealth Medical Center

  STUDY CHAIR

• Otto Costantini, MD

  MetroHealth Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2001
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 13, 2023

Record last verified: 2019-02