Viewing Study NCT03726463



Ignite Creation Date: 2024-05-06 @ 12:17 PM
Last Modification Date: 2024-10-26 @ 12:57 PM
Study NCT ID: NCT03726463
Status: UNKNOWN
Last Update Posted: 2019-03-11
First Post: 2018-10-28

Brief Title: Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD
Sponsor: Asan Medical Center
Organization: Asan Medical Center

Study Overview

Official Title: Evaluation of Intima and Media Layer of Iliac and Renal Artery to Verify a Mechanism of Intracranial Aneurysm Development in Autosomal Dominant Polycystic Kidney Disease Patients
Status: UNKNOWN
Status Verified Date: 2019-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: ADPKD is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the US ADPKD consists of 28 of patients receiving kidney transplantation in our center It is known that ADPKD is associated with vascular anomalies including abdominal aneurysms valvular anomalies and especially intracranial aneurysms Intracranial aneurysms occur in 912 of the ADPKD population which is higher than 23 in the general population and is known to be associated with PKD1 or PKD2 heritage

Until now most of the studies regarding intracranial aneurysms in ADPKD are conducted in animal models and there are only few cellular studies conducted from human samples While performing kidney transplantation to ESRD ADPKD patients arterial tissues from nephrectomy specimens can be obtained The objective of this study is to investigate the mechanism of intracranial aneurysm in ADPKD patients by analyzing iliac and renal artery characteristics
Detailed Description: ADPKD is associated with PKD1 gene on chromosome 16 and PKD2 gene on chromosome 4 and these gene respectively code polycystin 1 and polycystin 2 Currently the hypotheses for increased intracranial aneurysm rate in ADPKD patients is that mutation of polycystin is not only confined to nephron tissues but also in endothelial cells and vascular smooth muscle cells and results in mutation of vascular phenotype Also recent studies show polycystin complex causes cystic changes through mutation in primary cilia in renal epithelium Wild type endothelial cells respond to fluid shear stress by regulating levels of intracellular calcium and nitric oxide however PKD1 or PKD2 mutation in fetal aortic endothelial cells revealed loss of these responses

During kidney transplantation bilateral nephrectomies are routinely performed to ADPKD patients In this study blood urine iliac artery and renal artery tissues will be collected from ADPKD patients receiving kidney transplantation to analyze the arterial characteristic and gene mutation of ADPKD patients The aim of this study is to evaluate mechanisms associated with intracranial aneurysm occurence in ADPKD patients by analyzing the genetic mutation and vascular deformities of these patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None