Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients

Coronary Artery Disease Clinical Trial

Official title:

Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00651521
• Other study ID #: IWW-0002
• Secondary ID: CGMH-IRB-96-1680
• Status: Active, not recruiting
• Start date: April 2009
• Est. completion date: March 2025

Study information

• Verified date: March 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 3.3 coronary lesions per person. The relative risk for death from myocardial infarction and CAD is 1.18 in CKD patients with GFR < 60 ml/min. 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 ml/min. The 1-year mortality rate in different CKD stage were 0.7% (normal renal function patients), 2.0% (patients with proteinuria), 3.5% (overt proteinuric patients) and 12.1% (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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 2025
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. CKD patients with typical angina or positive electrocardiographic finding for myocardia ischemia.

2. Aged 20-80 years.

Exclusion criteria:

1. recipient of renal transplant graft or dialysis therapy

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Coronary Artery Disease
• Coronary Disease
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Taiwan	Department of Nephrology,Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Aronow WS, Ahn C, Mercando AD, Epstein S. Prevalence of coronary artery disease, complex ventricular arrhythmias, and silent myocardial ischemia and incidence of new coronary events in older persons with chronic renal insufficiency and with normal renal function. Am J Cardiol. 2000 Nov 15;86(10):1142-3, A9. — View Citation

Keough-Ryan TM, Kiberd BA, Dipchand CS, Cox JL, Rose CL, Thompson KJ, Clase CM. Outcomes of acute coronary syndrome in a large Canadian cohort: impact of chronic renal insufficiency, cardiac interventions, and anemia. Am J Kidney Dis. 2005 Nov;46(5):845-55. — View Citation

Reddan DN, Szczech L, Bhapkar MV, Moliterno DJ, Califf RM, Ohman EM, Berger PB, Hochman JS, Van de Werf F, Harrington RA, Newby LK. Renal function, concomitant medication use and outcomes following acute coronary syndromes. Nephrol Dial Transplant. 2005 Oct;20(10):2105-12. Epub 2005 Jul 19. — View Citation

Reddan DN, Szczech LA, Tuttle RH, Shaw LK, Jones RH, Schwab SJ, Smith MS, Califf RM, Mark DB, Owen WF Jr. Chronic kidney disease, mortality, and treatment strategies among patients with clinically significant coronary artery disease. J Am Soc Nephrol. 2003 Sep;14(9):2373-80. — View Citation

Reis SE, Olson MB, Fried L, Reeser V, Mankad S, Pepine CJ, Kerensky R, Merz CN, Sharaf BL, Sopko G, Rogers WJ, Holubkov R. Mild renal insufficiency is associated with angiographic coronary artery disease in women. Circulation. 2002 Jun 18;105(24):2826-9. — View Citation

Stack AG. Coronary artery disease and peripheral vascular disease in chronic kidney disease: an epidemiological perspective. Cardiol Clin. 2005 Aug;23(3):285-98. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause death	number of death	10 years
Primary	change of renal function	number to dialysis	10 years