Viewing Study NCT00651521



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Last Modification Date: 2024-10-26 @ 9:47 AM
Study NCT ID: NCT00651521
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2020-03-10
First Post: 2008-03-30

Brief Title: Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2020-03
Last Known Status: None
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: The prevalence and mortality rate of cardiovascular disease CVD in chronic kidney disease CKD patients is high The prevalence of coronary artery disease CAD in CKD population ranges from 38 to 65 with an average of 33 coronary lesions per person The relative risk for death from myocardial infarction and CAD is 118 in CKD patients with GFR 60 mlmin Because of this high prevalence of CAD and its high mortality reducing and preventing CAD risk factors is crucial in the clinical management of CKD patients

Low glomerular filtration rate GFR constitutes an important independent risk factor for CAD Several pathogenic factors play role in the genesis of cardiovascular dysfunction in chronic kidney disease Increased traditional CAD risk factor endothelial dysfunction sympathetic hyperactivity renin-angiotensin system activation increased glycosylated end products all contribute to the characteristic medial calcification of cardiovascular disease in CKD patients Hypertension fluid overloading and anemia further aggravated the cardiac loading leading to myocardial hypertrophy with chamber dilatation heart failure and death

The mortality rate of CAD in CKD patients is extremely high The NHANES II National Health and Nutritional Evaluation Survey found an increased of mortality rate 51 when the GFR decreased from 90 to 70 mlmin The 1-year mortality rate in different CKD stage were 07 normal renal function patients 20 patients with proteinuria 35 overt proteinuric patients and 121 dialysis patients respectively However the clinical feature and outcome of CAD in different stage of CKD remains unclear

We conducted a retrospective cohort study involving all patients admitted for coronary angiography from 1992 to 2004 The patients were categorized into five stages of CAD to compare the risk factor clinical feature and outcome Determination of this relationship can help to establish factors for early detection of CAD in CKD patients and also prognostic factor to improve outcome of these patients
Detailed Description: All patients who underwent cardiac catheterization for assessment of CAD at Keelung Chang Gung Memorial Hospital between 1992 and 2004 with continuous serum creatinine values measured before admission were included in this analysis Data were obtained from medical records of the database center of our institution Demographic and clinical data were assessed The age sex body mass index BMI body surface area BSA underlying comorbidities CAD risk factors including diabetes mellitus hypertension dyslipidemia smoking and obesity defined as a BMI 30 and clinical presentation were included in this study Hemodynamic parameters including the systolic and diastolic blood pressure heart rate and left ventricular ejection fraction were also obtained Coronary angiography was performed using a low-osmolarity non-ionic contrast medium iodixanol by experienced cardiologist Coronary artery disease was defined as a 50 or greater lumen narrowing of a major epicardial artery or its branches A left main stenosis of 50 or greater was regarded as equivalent to 2-vessel disease Blood samples were collected during admission before angiographic procedure Values of hemoglobin white blood cells platelet high sensitivity C-reactive protein hs-CRP and troponin I was included The treatment modality was divided into three categories medical percutaneous coronary intervention PCI including balloon angioplasty with or without stent placement and coronary artery bridge graft CABG on the basis of clinical condition and angiographic finding The outcome was followed-up until 12 months after angiographic procedure The estimated total study patient number is approximately 1000 patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CGMH-IRB-96-1680B None None None