NCT00651521

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

12.9 years

First QC Date

March 30, 2008

Last Update Submit

March 6, 2020

Conditions

Keywords

Angiographic CADChronic kidney diseaseLeft ventricular dysfunctionBody mass indexCardiovascular mortalityCoronary angiography

Outcome Measures

Primary Outcomes (2)

  • all cause death

    number of death

    10 years

  • change of renal function

    number to dialysis

    10 years

Study Arms (6)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All CKD patients admitted for coronary angiography from 1992 to 2019. The patients were further categorized into five stages of CKD.

You may qualify if:

  • CKD patients with typical angina or positive electrocardiographic finding for myocardia ischemia.
  • Aged 20-80 years.

You may not qualify if:

  • \. recipient of renal transplant graft or dialysis therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology,Chang Gung Memorial Hospital

Keelung, 240, Taiwan

Location

Related 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. doi: 10.1016/s0002-9149(00)01176-0.

    PMID: 11074216BACKGROUND
  • 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. doi: 10.1093/ndt/gfh981. Epub 2005 Jul 19.

    PMID: 16030030BACKGROUND
  • 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. doi: 10.1097/01.asn.0000083900.92829.f5.

    PMID: 12937316BACKGROUND
  • 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. doi: 10.1161/01.cir.0000021597.63026.65.

    PMID: 12070108BACKGROUND
  • Stack AG. Coronary artery disease and peripheral vascular disease in chronic kidney disease: an epidemiological perspective. Cardiol Clin. 2005 Aug;23(3):285-98. doi: 10.1016/j.ccl.2005.04.003.

    PMID: 16084278BACKGROUND
  • 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. doi: 10.1053/j.ajkd.2005.07.043.

    PMID: 16253724BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseRenal Insufficiency, ChronicVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular Dysfunction

Study Officials

  • Iwen Wu, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

April 1, 2009

Primary Completion

March 1, 2022

Study Completion

March 1, 2025

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations