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A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data (PREDICT-ICDS)

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ClinicalTrials.gov Identifier: NCT01822145
Recruitment Status : Unknown
Verified September 2015 by Ngai Yin Chan, Princess Margaret Hospital, Hong Kong.
Recruitment status was:  Recruiting
First Posted : April 2, 2013
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong

Brief 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

Condition or disease Intervention/treatment
Sudden Cardiac Arrest Ventricular Tachycardia Ventricular Fibrillation Device: ICD

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
Study Start Date : March 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016


Group/Cohort Intervention/treatment
ICD recipients
ICD recipients with documented cardiac arrest or ventricular arrhythmias
Device: ICD



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation
Criteria

Inclusion Criteria:

  1. Age ≧ 18 and ≦ 80
  2. Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
  3. Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
  4. Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
  5. Patients who are compliant to CareLink follow-up

Exclusion Criteria:

  1. Patients who are pregnant
  2. Patients who are incapable of giving consent to the study
  3. Patients who have a life-expectancy of less than 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822145


Contacts
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Contact: Ngai Yin Chan, MBBS 852 2990 1111 ngaiyinchan@yahoo.com.hk

Locations
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China
Princess Margaret Hospital Recruiting
Hong Kong, China, 999077
Contact: Ngai Yin Chan, MBBS    852 29901111    ngaiyinchan@yahoo.com.hk   
Principal Investigator: Ngai Yin Chan, MBBS         
Sponsors and Collaborators
Princess Margaret Hospital, Hong Kong
Investigators
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Principal Investigator: Ngai Yin Chan, MBBS Princess Margaret Hospital, Canada

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Responsible Party: Ngai Yin Chan, Principal investigator, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01822145     History of Changes
Other Study ID Numbers: PREDICTICDS01
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by Ngai Yin Chan, Princess Margaret Hospital, Hong Kong:
implantable-cardioverter-defibrillator
ventricular tachycardia
ventricular fibrillation
sudden cardiac arrest

Additional relevant MeSH terms:
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Ventricular Fibrillation
Heart Arrest
Tachycardia
Tachycardia, Ventricular
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Death, Sudden
Death