Genome-Wide Association Study With the Aim of Implantable Cardioverter Defibrillator Implantation Genophenotypic Risk Stratification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ICD Arrythmia Sudden Cardiac Death

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Experimental group

Patients with ICD who received at least one electric shock in 6 months after ICD implantation

Non-Invasive saliva sampling

Intervention Type OTHER

There 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.

Control Group

Patients with ICD who didnot received any electric shock in 6 months after ICD implantation

Non-Invasive saliva sampling

Intervention Type OTHER

There 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.

Healthy Group

Healthy Volunteers This group will be used for related bioinformatic analysis (DATA analysis stage) but not in statistical analysis

Non-Invasive saliva sampling

Intervention Type OTHER

There 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.

Interventions

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Non-Invasive saliva sampling

There 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.

Intervention Type OTHER

Other Intervention Names

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ICD

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes