An observational study in ICD, Arrythmia and Sudden Cardiac Death, sponsored by Selcuk University. Status unknown at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by Selcuk University · Observational
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Selcuk University is the lead sponsor of 248 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with ICD who received at least one electric shock in 6 months after ICD implantation
Other: Non-Invasive saliva sampling
Patients with ICD who didnot received any electric shock in 6 months after ICD implantation
Other: Non-Invasive saliva sampling
Healthy Volunteers This group will be used for related bioinformatic analysis (DATA analysis stage) but not in statistical analysis
Other: 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.
Also known as: ICD
Revealing SNP variants related to phenotypic measurement factors
ICD Shock, Sudden Cardiac Death, Ventricular Arrythmia and ICD prognosis related genetic polymorphism variant
Time frame: 2024MAY
GENOPHENOTYPIC risk stratification
Results of genotype and phenotype statistical analysis
Time frame: 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
Time frame: 2025MARCH
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
Time frame: 2025MARCH
comprehensive local demographic statistics
since a large-scale study is desired, valuable domestic demographic statistical data can be achieved
Time frame: 2024DEC
Plan to share: No
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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Selcuk University