ICDICDGPSSNCT05582252
Genome-Wide Association Study With the Aim of Implantable Cardioverter Defibrillator Implantation Genophenotypic Risk Stratification
An observational study of ICD and Arrythmia, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study will be conducted with funding from European Innovation Council(EIC) after approval of the fund grant and is part of our organization's European Pathfinder Project(Ref: HORIZON-EIC-2022-PATHFINDERCHALLENGES-01). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ICD, Arrythmia, Sudden Cardiac Death
- What is being tested?
- Non-Invasive saliva sampling
- How many people
- 2,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2023to Mar 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population are the ICD-implanted patients according to exclusion and inclusion criteria. No randomization will be done for patient selection and group allocation (the validation stage will be done by randomization). An extra-healthy volunteer will be included for bioinformatic data analysis.
Who may be able to join
- ICD-implanted patients (both for primary and secondary intervention)
- Being a volunteer for the study
- Adequacy in understanding the study risks and accepting the Informed Consent Form
- Official acceptance of the legal and official parents (both father and mother), If younger than 18 years old
Who cannot join
- The patient who does not volunteer to involve to the study.
- Diagnosis of underlying arrhythmogenic disease (Structural Heart disease, Brugada, Arrhythmogenic right ventricular dysplasia, etc.)
- Development of electric shock due to acute coronary syndrome
- Atrial Fibrillation (AFib) With Rapid Ventricular Response
- Electric shock in patients with electrolyte imbalance-induced VT/VF
- Electric Shock in a patient with acute myocarditis-induced ventricular arrhythmias
- Patients that had an electric shock because of pacing / ATP ramp-induced VT (RV/CRT Pacing)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Genetic Department Faculty of Medicine
Konya
TULUN CORA, Ph.D., +905323673777, tulincora@selcuk.edu.tr
EBRU OZDEMIR, MD., +90506 351 0721, ebru.ozdemir@selcuk.edu.tr
About this study
Official title: The Comprehensive Investigation to Define a New Scoring System for ICD Implantation Based on Genotypic and Phenotypic Criteria; A Multidisciplinary and Multicentral Genome-Wide Association Study
This clinical study will be conducted with funding from European Innovation Council(EIC) after approval of the fund grant and is part of our organization's European Pathfinder Project(Ref: HORIZON-EIC-2022-PATHFINDERCHALLENGES-01). The clinical study step of this project will be started in a retrospective time prospective manner by gathering the phenotypic(clinical measuring factors) data from patients who underwent ICD implantation therapy. The study will be done as a case-control type in which patients who did not get any shocks in 6 months post-implantation will be allocated to the control group. A customized and highly specific cardiogenomics panel will be designed and ordered to be specially manufactured as a standard kit by Illumina® (San Diego, California, U.S.) following an exhaustive investigation for collecting genetic variants which correlated to cardiovascular development. Mentioned kit bears the standard and validated technology which is part of the genetic tests routine and is being produced by Illumina® incorporate. However, as an option manufacturer is designing custom kits for research purposes by getting the desired variant lists using the same technology. Accordingly, enrolled patients in the study will be prospectively sampled ( Non-Invasive saliva sampling) for getting genetically analysed by Illumina®'s Infinium Assay Microarray platform with fully customized 700,000 single nucleotide polymorphism kits. The result of this sampling will be data and statistically analysed in a genome-wide association study(GWAS) manner by considering the 5x10-8 p.value and will be associated with each phenotypic parameter. Accordingly, the study will assess the genetic risk stratification in ICD patients in a much more detailed fashion. Following this assessment genophenotypic statistical analysed will be done to combine both parameters and generate a formula for scoring the indicator factors based on each odds ratio. Correspondingly, this new scaling formula will be analysed, verified and validated further by a randomized sampling of the population in our study before being stated. Additionally, This study will not only help to improve current genetic polymorphism clinal significant status (pathogenicity and significance of variant) but also can associate new markers with high significance that can be directly used in clinical screening, diagnosis or clinical approaches.
- Conditions
- ICD, Arrythmia, Sudden Cardiac Death
- Being tested
- Non-Invasive saliva sampling
- Keywords
- Implantable Cardioverter Defibrillators, Ventricular Arrhythmia, Sudden Cardiac Death, Cardiogenomics, Cardiogenetics, GWAS, Genetic Polymorphism
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive saliva samplingOther
Also called ICD
There are two types of intervention in this ambidirectional study.
- Non-Invasive Saliva Sampling will be done for DNA extraction for the purpose of genetic analysis. This would be the prospective sampling and it's not part of the related medical centre's clinical routine.
- ICD that is already implanted in the patients and had been indicated by related medical centre's clinical routine approach. This is not a prospective approach to this study since the study would be retrospectively gathered phenotypic parameters from the hospital data records.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients with ICD who received at least one electric shock in 6 months after ICD implantation Receives: Other: Non-Invasive saliva sampling | |
| Control Group | Patients with ICD who didnot received any electric shock in 6 months after ICD implantation Receives: Other: Non-Invasive saliva sampling | |
| Healthy Group | Healthy Volunteers This group will be used for related bioinformatic analysis (DATA analysis stage) but not in statistical analysis Receives: Other: Non-Invasive saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revealing SNP variants related to phenotypic measurement factors
ICD Shock, Sudden Cardiac Death, Ventricular Arrythmia and ICD prognosis related genetic polymorphism variant
Measured: 2024MAY
GENOPHENOTYPIC risk stratification
Results of genotype and phenotype statistical analysis
Measured: 2024DEC
Comprehensive genophenotypic scoring system formula
a formula that is based on genetic and phenotypic parameters that can be used as criteria for ICD implantation indication
Measured: 2025MARCH
Secondary outcomes (1)
offering a comprehensive cardiogenetic kit
a kit that is based on the Illumina bead chip Infinium Microarray technology and can be used for research, clinical screening and diagnosis
Measured: 2025MARCH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study startFeb 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, TC Erciyes University, Dokuz Eylul University
- Responsible party
- Principal investigator, Ebru Marzioglu Ozdemir, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582252
- Sponsor's protocol ID
- KINASK-ICDGPSS-EICCG2210
- Other IDs
- DN2022/400-MN2022/17
- Acronym
- ICDGPSS
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comprehensive Investigation to Define a New Scoring System for ICD Implantation Based on Genotypic and Phenotypic Criteria; A Multidisciplinary and Multicentral Genome-Wide Association Study
- ClinicalTrials.gov ID
- NCT05582252
- Acronym / sponsor ID
- ICDGPSS / KINASK-ICDGPSS-EICCG2210
- Conditions
- ICD, Arrythmia, Sudden Cardiac Death
- Keywords
- Implantable Cardioverter Defibrillators, Ventricular Arrhythmia, Sudden Cardiac Death, Cardiogenomics, Cardiogenetics, GWAS, Genetic Polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Ankara University, TC Erciyes University, Dokuz Eylul University
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Oct 2022 (actual)
- 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.
This clinical study will be conducted with funding from European Innovation Council(EIC) after approval of the fund grant and is part of our organization's European Pathfinder Project(Ref: HORIZON-EIC-2022-PATHFINDERCHALLENGES-01). The clinical study step of this project will be started in a retrospective time prospective manner by gathering the phenotypic(clinical measuring factors) data from patients who underwent ICD implantation therapy. The study will be done as a case-control type in which patients who did not get any shocks in 6 months post-implantation will be allocated to the control group. A customized and highly specific cardiogenomics panel will be designed and ordered to be specially manufactured as a standard kit by Illumina® (San Diego, California, U.S.) following an exhaustive investigation for collecting genetic variants which correlated to cardiovascular development. Mentioned kit bears the standard and validated technology which is part of the genetic tests routine and is being produced by Illumina® incorporate. However, as an option manufacturer is designing custom kits for research purposes by getting the desired variant lists using the same technology. Accordingly, enrolled patients in the study will be prospectively sampled ( Non-Invasive saliva sampling) for getting genetically analysed by Illumina®'s Infinium Assay Microarray platform with fully customized 700,000 single nucleotide polymorphism kits. The result of this sampling will be data and statistically analysed in a genome-wide association study(GWAS) manner by considering the 5x10-8 p.value and will be associated with each phenotypic parameter. Accordingly, the study will assess the genetic risk stratification in ICD patients in a much more detailed fashion. Following this assessment genophenotypic statistical analysed will be done to combine both parameters and generate a formula for scoring the indicator factors based on each odds ratio. Correspondingly, this new scaling formula will be analysed, verified and validated further by a randomized sampling of the population in our study before being stated. Additionally, This study will not only help to improve current genetic polymorphism clinal significant status (pathogenicity and significance of variant) but also can associate new markers with high significance that can be directly used in clinical screening, diagnosis or clinical approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Non-Invasive saliva samplingPatients with ICD who received at least one electric shock in 6 months after ICD implantation |
| Control Group | – | Other: Non-Invasive saliva samplingPatients with ICD who didnot received any electric shock in 6 months after ICD implantation |
| Healthy Group | – | Other: Non-Invasive saliva samplingHealthy Volunteers This group will be used for related bioinformatic analysis (DATA analysis stage) but not in statistical analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are the ICD-implanted patients according to exclusion and inclusion criteria. No randomization will be done for patient selection and group allocation (the validation stage will be done by randomization). An extra-healthy volunteer will be included for bioinformatic data analysis.
Key inclusion criteria (4 listed)
- ICD-implanted patients (both for primary and secondary intervention)
- Being a volunteer for the study
- Adequacy in understanding the study risks and accepting the Informed Consent Form
- Official acceptance of the legal and official parents (both father and mother), If younger than 18 years old
Key exclusion criteria (7 listed)
- The patient who does not volunteer to involve to the study.
- Diagnosis of underlying arrhythmogenic disease (Structural Heart disease, Brugada, Arrhythmogenic right ventricular dysplasia, etc.)
- Development of electric shock due to acute coronary syndrome
- Atrial Fibrillation (AFib) With Rapid Ventricular Response
- Electric shock in patients with electrolyte imbalance-induced VT/VF
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 |
|---|---|---|
| Non-Invasive saliva samplingAlso: ICDThere are two types of intervention in this ambidirectional study. 1. Non-Invasive Saliva Sampling will be done for DNA extraction for the purpose of genetic analysis. This would be the prospective sampling and it's not part of the related medical centre's clinical routine. 2. ICD that is already implanted in the patients and had been indicated by related medical centre's clinical routine approach. This is not a prospective approach to this study since the study would be retrospectively gathered phenotypic parameters from the hospital data records. | Other | Control Group, Experimental group, Healthy Group |
Primary outcome
Revealing SNP variants related to phenotypic measurement factors
Time frame: 2024MAY
ICD Shock, Sudden Cardiac Death, Ventricular Arrythmia and ICD prognosis related genetic polymorphism variant
GENOPHENOTYPIC risk stratification
Time frame: 2024DEC
Results of genotype and phenotype statistical analysis
Comprehensive genophenotypic scoring system formula
Time frame: 2025MARCH
a formula that is based on genetic and phenotypic parameters that can be used as criteria for ICD implantation indication
1 secondary outcome
offering a comprehensive cardiogenetic kit
Time frame: 2025MARCH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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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.
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 ICD and Arrythmia, run by Selcuk University at 1 site in Turkey (Türkiye).
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 7 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 17 Oct 2022. 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 Turkey (Türkiye). 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 EBRU M Ozdemir, MD. (++905063510721, ebru.ozdemir@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revealing SNP variants related to phenotypic measurement factors (time frame: 2024MAY). The study lists 3 primary outcomes in all. 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 17 Oct 2022.