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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
iwenwu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00651521
First received: March 30, 2008
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition
Coronary Artery Disease
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • all cause death [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Groups/Cohorts
1
CKD stage 1 patients
2
CKD stage 2 patients
3
CKD stage 3a patients
4
CKD stage 3b patients
5
CKD stage 4 patients
6
CKD stage 5 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All CKD patients admitted for coronary angiography from 1992 to 2004. The patients were further categorized into five stages of CKD.

Criteria

Inclusion Criteria:

  • CKD patients with typical angina or positive electrocardiographic finding for myocardia ischemia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651521

Contacts
Contact: I Wen Wu, MD +886-2-24313131 ext 3169 a22066@adm.cgmh.org.tw

Locations
Taiwan
Department of Nephrology,Chang Gung Memorial Hospital Recruiting
Keelung, Taiwan, 240
Contact: I Wen Wu, MD    +886-2-24313131 ext 3169    a22066@adm.cgmh.org.tw   
Principal Investigator: Iwen Wu, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Iwen Wu, MD Chang Gung Memorial Hospital
  More Information

Publications:

Responsible Party: iwenwu, Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00651521     History of Changes
Other Study ID Numbers: IWW-0002, CGMH-IRB-96-1680B
Study First Received: March 30, 2008
Last Updated: December 24, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Angiographic CAD
Chronic kidney disease
Left ventricular dysfunction
Body mass index
Cardiovascular mortality
Coronary angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014