Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02491853 |
| Other study ID # |
GulfICD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 1, 2015 |
| Last updated |
August 11, 2016 |
| Start date |
January 2014 |
| Est. completion date |
June 2016 |
Study information
| Verified date |
August 2016 |
| Source |
Gulf Heart Association |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Qatar: Hamad Medical Corporation |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This is a prospective observational multi-center multi-national study of the characteristics
and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab
Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical
characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as
mortality and ICD discharges over 1 year of follow-up will be collected.
Description:
1. INTRUDUCTION 1.1 Background and Rationale The implantable cardioverter-defibrillator
(ICD) is an effective tool for the prevention of sudden cardiac death (SCD) in
high-risk patients. The efficacy of the ICD in the secondary and primary prevention of
SCD was demonstrated in several large randomized clinical trials. The evolution of
clinical trials of ICD therapy for primary prevention of SCD and the adoption of
current national practice guidelines has lead to a considerable increase in the use of
ICDs worldwide. In the Arab Gulf region, utilization of ICD therapy in high-risk
patients had increased in the past decade with the arrival of trained
electrophysiologists in the Gulf states. While observational studies in the United
States and Europe have evaluated ICD use in those regions, there are scarce data on how
ICDs are being used in the Gulf. Few single center studies have reported early results,
and to date there are no prospective multinational data on ICD use in the Gulf. The
Gulf Implantable Cardioverter-Defibrillator Registry (GulfICD) will be the first
prospective, multicentre, multinational, observational studies of patients receiving
ICDs in the Arab Gulf states.
2. STUDY OBJECTIVES AND ENDPOINTS The primary objective of the study is to describe the
characteristics and outcomes of patients receiving ICD in the Arab Gulf region. Once
completed, the data collected from GulfICD will be available for further secondary
analyses including a description of ICD implant indications and programming patterns in
the Gulf. As this is an observational and descriptive study, no specific endpoint is
considered primary. However, main outcomes to be measured include all-cause mortality
and ICD discharges including appropriate discharges for ventricular tachyarrhythmias
and inappropriate discharges for other causes. Other endpoints to be measured include
adverse events in the immediate post-implant period.
3. STUDY DESIGN Gulf ICD is a prospective, multicentre, multinational observational study.
4. SUBJECT SELECTION 4.1 Inclusion Criteria All adult patients 18 years or older,
receiving a new ICD implant and willing to sign a consent form will be eligible.
4.2 Exclusion Criteria Patients < 18 years and those not willing to sign a consent
form. Subjects with existing ICDs undergoing pulse generator replacements or system
revisions will not be included.
5. STUDY TREATMENTS All subjects will be treated per routine clinical practice. There will
be no study-specific interventions/treatments.
6. STUDY PROCEDURES 6.1 Subject Withdrawal Subjects will have the right to withdraw from
the study at anytime.
7. DATA VARIABLES 7.1 Data Variables Data variables to be collected are detailed in the
attached case-report form(CRF) (Baseline CRF Appendix 1, Follow Up CRF Appendix 2).
Data will be collected on paper CRF and then entered online. Variables to be collected
at baseline will include the following domains: 1. Baseline Demographics, 2. Admission
Characteristics, 3. Medical History and Risk Factors, 4. Diagnostic Procedures, 5. ICD
Implant Procedure Characteristics, 6. ICD Programming, 7. Adverse Events, 8. Discharge
Characteristics, 9. Discharge Medications, 10. Interim Events (during follow up).
Variable definitions will be based on the American College of Cardiology/American Heart
Association/Heart Rhythm Society 2006 Key Data Elements and Definitions for
Electrophysiological Studies and Procedures and the American College of Cardiology
National Cardiovascular Data Registry (NCDR) ICD Registry data dictionary
(httpp://www.ncdr.com/Web
NCDR/docs/public-data-collection-documents/icd_v2_datadictionary_codersdictionary_2-1.pdf?sfvrsn=2)
8. ADVERSE EVENT REPORTING 8.1 Adverse Events Reporting Since there will be no
study-specific intervention/treatment, we do not expect study specific adverse events.
However, adverse events that may be related to ICD implantation will be collected as
per the attached CRF (Appendix 1).
9. DATA ANALYSIS 9.1 Sample Size Considerations Unlike randomized controlled trials where
specific hypotheses are tested and primary comparative analyses are planned,
observational studies and patient registries typically address descriptive objectives.
Such objectives do not lend themselves to classic sample size/power calculations.
Nonetheless, sample size considerations are important in the planning of registries.
Typically, adequate sample size is required to ensure adequate precision around key
outcomes and provide sufficient generalizability. With that in mind, we wanted to
ensure adequate precision around two key outcomes: all-cause mortality and/or rate of
appropriate ICD discharges at one year. To estimate an event rate of 10% at 1 year with
a margin of error of 2% and 95% confidence intervals, a sample size of 829 patients is
required. Since there is little guidance in the literature on such event rates among
ICD recipients in the Gulf, and to compensate for losses to follow-up, we adjusted our
sample size upwards to 1,000 patients. Sample size was later increased to 1,500
patients as additional funding became available. Such a sample size was considered
logistically feasible given our experience with ICD implant rates in the Gulf.
9.2 Statistical Methods Standard descriptive statistics will be used to analyse the
data. Continuous variables will be summarized using mean and standard deviation or
median and 25th and 75th percentile when significant deviation from a normal
distribution is observed. Categorical variables will be summarized using counts and
percentages. Basic univariate comparisons will be performed using Student's t-test or
the Wilcoxon rank sum test as appropriate for continuous variables, and the Chi square
test for categorical variables. Associations between baseline variables and outcomes
during follow-up will be assessed using logistic regression or when exact event dates
are available Cox proportional hazard models.
10. QUALITY CONTROL AND QUALITY ASSURANCE There is no substitute for good conscious. The
investigators and their personnel filling the CRFs are responsible for filling the
forms honestly and accurately. All forms must be filled prospectively. Quality control
checking mechanisms are implemented in the online CRF system to prevent entry of
inconsistent variables.
11. DATA HANDLING AND RECORD KEEPING 11.1 Case Report Forms/Electronic Data Records A CRF
is required and should be collected and completed for each patient. Online data entry
of the CRF will be available.
11.2 Record Retention Investigators will retain the paper CRFs per local ethics
regulations. Paper CRFs will be stored in a secure area with access only available to
study investigators. The online CRF portal will be password protected.
12. ETHICS 12.1 Institutional Review Board/Ethics Committee Approval It is the
responsibility of the investigator to get prospective approval of the study protocol,
consent form, and any amendments from the local institutional review boards/ethic
committee.
12.2 Ethical Conduct of the Study The study will be conducted in accordance with the
protocol and applicable local regulatory requirements and laws. Study conduct will also
conform to the Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human Subjects adopted by the General Assembly of the World Medical
Association
12.3 Subject Information and Consent All investigators will ensure protections of
subjects' personal data and subject names or identifiers will not be included on any
reports or publications from the study. Each study subject will be informed about the
study objectives and procedures and all questions will be answered. Subjects will have
to sign a consent form to be enrolled in the study. The consent form must be in
compliance with local regulatory requirements.
13. SPONSORSHIP GulfICD will be conducted under the auspices of the Gulf Heart Rhythm
Society (GHRS) and the Gulf Heart Association (GHA). Partial funding for the
development of the online CRF portal is provided by Medtronic, Inc.
14. STUDY STRUCTURE AND TIMELINE 14.1 Principal Investigators and Steering Committee
Members The study co-principal investigators are: Dr Alawi Alsheikh-Ali, Dr Ahmad Hersi
and Dr Adel Khalifa. Country-level Principal Investigators include: Dr Najib Alrawahi
(Principal Investigator Gulf ICD-Oman), Dr Nidal Asaad (Principal Investigator Gulf
ICD-Qatar), additional steering committee members at the time of this righting are: Dr
Fayez Bokhari, Dr Ahmad Alfaqih and Dr Amin Daoulah (Kingdom of Saudi Arabia), Dr
Fawzieh Alkandari (Kuwait), Dr Salim Al-Kaabi, Dr Omer Elhag, Dr Hani Sabbour and Dr
Hosam Zaky (United Arab Emirates). Additional members will be added to the steering
committee as more centers join the study.
14.2 Study Timeline
Below is a tentative study timeline:
Milestone Date Initial talks between GHRS and Medtronic October 2011 Formal
solicitation of funding submitted to Medtronic April 2012 Funding approved by Medtronic
June 2012 Contract Signed with software company to develop online CRF system November
2012 Draft protocol and CRF circulated to Steering Committee December 2012 Development
of online CRF portal and finalizing protocol December 2012-July 2013 Final protocol and
CRF approved by steering committee August 2013 Submit for Institutional Review
Board(IRB) approvals August/September 2013 Pilot online CRF September/October 2013
Official study launch November 2013 Submit "Methodology manuscript" December 2013
Complete enrolment November 2014 Complete follow-up for all patients November 2015 Data
cleaning throughout study duration Data lockout January 2016 Start data analysis
January 2016 Draft "main results manuscript" March 2016 Submit "main results
manuscript" May 2016 Drafting and submissions of other manuscripts May 2016 onwards
15. PUBLICATION OF STUDY RESULTS Results of GulfICD will be disseminated through
peer-reviewed manuscripts, abstracts, and presentations. The co-principal investigators
and steering committee will be solely responsible for analysis, writing, and decision
to submit for publications/presentation of all abstracts and manuscripts. Members of
the steering committee will be co-authors on all study manuscripts that utilize the
shared registry data. Manuscripts/abstracts based on country- or site-level data will
require co-authorship by all steering committee members from the relevant country or
site. Outside co-authors will be included if they meet the authorship requirements per
the guidelines established by the International Committee of Medical Journal Editors
and outlined in "Uniform Requirements for Manuscripts Submitted to Biomedical Journals;
http://www.icmje.org/ethical_1author.html".
