Sudden Cardiac ArrestPREDICT-ICDSNCT01822145
A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data
An observational study of Sudden Cardiac Arrest and Ventricular Tachycardia, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
Trial summary
The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- ICD
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jan 2016
- 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: ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation
Who may be able to join
- Age ≧ 18 and ≦ 80
- Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
- Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
- Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
- Patients who are compliant to CareLink follow-up
Who cannot join
- Patients who are pregnant
- Patients who are incapable of giving consent to the study
- Patients who have a life-expectancy of less than 2 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Hong Kong, 999077
Ngai Yin Chan, MBBS, 852 29901111, ngaiyinchan@yahoo.com.hk
Ngai Yin Chan, MBBS
About this study
Official title: PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD
- Being tested
- ICD
- Keywords
- implantable-cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, sudden cardiac arrest
- Medical subject headings
- Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
| Study group | Role | What they receive |
|---|---|---|
| ICD recipients | ICD recipients with documented cardiac arrest or ventricular arrhythmias Receives: Device: ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD-derived T-wave alternans amplitude before ICD shock
The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
- Investigators
- Ngai Yin Chan, MBBS, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822145
- Sponsor's protocol ID
- PREDICTICDS01
- Acronym
- PREDICT-ICDS
- Status last verified
- Sep 2015
- First submitted
- 24 Mar 2013
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
- ClinicalTrials.gov ID
- NCT01822145
- Acronym / sponsor ID
- PREDICT-ICDS / PREDICTICDS01
- Keywords
- implantable-cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, sudden cardiac arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 2 Apr 2013 (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 primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD recipients | – | Device: ICDICD recipients with documented cardiac arrest or ventricular arrhythmias |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation
Key inclusion criteria (5 listed)
- Age ≧ 18 and ≦ 80
- Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
- Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
- Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
- Patients who are compliant to CareLink follow-up
Key exclusion criteria (3 listed)
- Patients who are pregnant
- Patients who are incapable of giving consent to the study
- Patients who have a life-expectancy of less than 2 years
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 |
|---|---|---|
| ICD | Device | ICD recipients |
Primary outcome
ICD-derived T-wave alternans amplitude before ICD shock
Time frame: 6 months
The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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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.
Ngai Yin Chan, MBBS principal investigator
Princess Margaret Hospital, Canada
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 Sudden Cardiac Arrest and Ventricular Tachycardia, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Sep 2015. 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 China. 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 Ngai Yin Chan, MBBS (852 2990 1111, ngaiyinchan@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICD-derived T-wave alternans amplitude before ICD shock (time frame: 6 months). 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 Sep 2015.