Coronary Artery DiseaseNCT00644345
T-Wave Alternans (TWA) Reproducibility in CAD Patients
An observational study of Coronary Artery Disease, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease enrolled in a cardiac rehabilitation program.
Who may be able to join
- Patients enrolled in the cardiac rehabilitation center program
- Patients with CAD
- Age >18 and < 80 YO
- Patients with a pacemaker or defibrillator with normal AV conduction
Who cannot join
- Patients with chronic AF
- Patients with multiple APB's or PVC's
- Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker.
- Patients who are unable to exercise on a bicycle.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center
Zrifin
Therese Fuchs, MD, 972-8-977-9735, fuchst@asaf.health.gov.il
Isaac Zysman, MD, 972-8-977-9735, zysmanI@asaf.health.gov.il
About this study
Official title: Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.
Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.
Read the detailed description
The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll.
Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.
- Conditions
- Coronary Artery Disease
- Keywords
- Microvolt T wave alternans, reproducibility
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of TWA test results
Measured: 1 week
Secondary outcomes (1)
Ventricular arrhythmias during exercise
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Therese Fuchs, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644345
- Sponsor's protocol ID
- 38-08
- Status last verified
- Mar 2008
- First submitted
- 23 Mar 2008
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.
- ClinicalTrials.gov ID
- NCT00644345
- Acronym / sponsor ID
- 38-08
- Conditions
- Coronary Artery Disease
- Keywords
- Microvolt T wave alternans, reproducibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 26 Mar 2008 (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.
Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.
Detailed description
The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll.
Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease enrolled in a cardiac rehabilitation program.
Key inclusion criteria (4 listed)
- Patients enrolled in the cardiac rehabilitation center program
- Patients with CAD
- Age >18 and < 80 YO
- Patients with a pacemaker or defibrillator with normal AV conduction
Key exclusion criteria (4 listed)
- Patients with chronic AF
- Patients with multiple APB's or PVC's
- Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker.
- Patients who are unable to exercise on a bicycle.
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
Reproducibility of TWA test results
Time frame: 1 week
1 secondary outcome
Ventricular arrhythmias during exercise
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
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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.
Therese Fuchs, MD principal investigator
Assaf-Harofeh 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 Coronary Artery Disease, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 4 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 26 Mar 2008. 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 Israel. 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?
Contact Therese Fuchs, MD (972-8-977-9735, fuchst@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of TWA test results (time frame: 1 week). 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 26 Mar 2008.