Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Chronic Kidney Disease	Drug: rosuvastatin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2998 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
Study Start Date :	December 2008
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	November 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; perioperative rosuvastatin administration for at least 5 dosages	Drug: rosuvastatin; rosuvastatin
Placebo Comparator: control; blank control of perioperative statin administration	Drug: rosuvastatin; rosuvastatin

Outcome Measures

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Primary Outcome Measures :

1. An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ]

Secondary Outcome Measures :

1. The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Planned diagnostic coronary or peripheral artery angiography
• T2DM
• CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
• Statin naive, or not on statin treatment for at least 14 days
• Withdrawal metformin or aminophylline for 48h before angiography
• Total iodixanol volume

Exclusion Criteria:

• Hypersensitivity to iodine-containing compounds and statins
• Type 1 diabetes mellitus
• Ketoacidosis
• Lactic acidosis
• CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR＜30ml/min per 1.73m2)
• STEMI
• NYHA class IV or hemodynamic instability
• Administration of any iodinated CM within 14 days before randomization
• LDL-C＜1.82mmol/L（70mg/dL）
• Hepatic dysfunction (ALT 3 times greater than upper normal limit)
• Thyreoid insufficiency
• renal artery Stenosis(unilateral ＞70％ or bilateral stenosis＞50％)

Contacts and Locations

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Locations

China, Beijing
The Armed Police General Hospital
BeiJing, Beijing, China, 100000
The Chinese people's liberation army general hospital affiliated hospitals
BeiJing, Beijing, China, 100000
Peking University first hospital
Beijing, Beijing, China, 100034
General Hospital Of The Second Artillery Force of the PLA
BeiJing, Beijing, China, 100088
The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
BeiJing, Beijing, China, 100853
China, Chongqing
The Third Military Medical University, Chongqing Xinqiao Hospital
ChongQing, Chongqing, China, 400037
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ChongQing, Chongqing, China, 400042
China, Gansu
First Hospital of Lanzhou University
LanZhou, Gansu, China, 730000
China, Guangdong
Dongguan Kanghua Hospital
DongGuan, Guangdong, China, 523080
General Hospital of Guangzhou Military Command of PLA
GuangZhou, Guangdong, China, 510010
The First Affiliated Hospital of Guangzhou Medical College
GuangZhou, Guangdong, China, 510120
China, Hebei
Chinese People's Liberation Army 252th Hostipal
BaoDing, Hebei, China, 610000
CanZhou Central Hospital
CangZhou, Hebei, China, 610001
Shijiazhuang International Peace Hospital
ShiJiaZhuang, Hebei, China, 600082
China, Heilongjiang
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
China, Henan
HeNan Provincial People's Hospital
ZhengZhou, Henan, China
China, Hubei
WuHan Asia Heart Hosital
WuHan, Hubei, China, 430022
WuHan Union Hospital Of China
WuHan, Hubei, China, 430022
TongJi Medical College HuaZhong University Of Science & Technology
WuHan, Hubei, China, 430030
Renmin Hospital Of Wuhan University
WuHan, Hubei, China, 430060
Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
WuHan, Hubei, China, 430070
China, Jiangsu
Nanjing First Hospital
NanJing, Jiangsu, China, 210006
NanJing Drum Tower Hospital
NanJing, Jiangsu, China, 210008
China, Jilin
FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
ChangChun, Jilin, China, 130011
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Changchun Central Hospital
ChangChun, Jilin, China, 130051
China, Liaoning
General Hospital of Liaoning Anshan Iron and Steel Group Corporation
AnShan, Liaoning, China, 114001
Affiliated Zhongshan Hospital of Dalian University
DaLian, Liaoning, China, 116001
Fushun central hospital
FuShun, Liaoning, China, 113006
The First Affiliated Hospital of Liaoning Medical College
Jinzhou, Liaoning, China, 121001
ShenZhou Hopital Of ShenYang Medical College
ShengYang, Liaoning, China, 110032
PLA 202 Hospital
ShenYang, Liaoning, China, 110004
Shenyang Nortern Hospital
Shenyang, Liaoning, China, 110016
Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
ShenYang, Liaoning, China, 110032
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110032
The 463th Hospital Of PLA
ShenYang, Liaoning, China, 110042
China, Ningxia
Affiliated Hospital of Ningxia Medical College
Yinchuan, Ningxia, China, 750004
China, Shandong
General Hospital of Jinan Military Area Command of Chinese PLA
JiNan, Shandong, China, 250031
88th Hospital of the Chinese PLA
TaiAn, Shandong, China, 271000
China, Shanghai
Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
ShangHai, Shanghai, China, 200025
China, Shanxi
Xijing Hospital of the Fourth Military Medical University
XiAn, Shanxi, China, 710032
China, Sichuan
Chengdu Military General Hospital
ChengDu, Sichuan, China, 610083
China, Tianjin
PLA 254 Hosipital
TianJin, Tianjin, China, 300142
Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
TianJin, Tianjin, China, 300162
China, Xinjiang
WuluMuqi General Hospital of PLA Lanzhou Military Area Command
WuLuMuQI, Xinjiang, China, 830000
The First Affilliated Hospital Of Xinjiang Medical University
Wulumuqi, Xinjiang, China, 830054
China, Yunnan
The First Affiliated Hospital of Kunming Medical College
KunMing, Yunnan, China, 650031
Kunming General Hospital of PLA
KunMing, Yunnan, China, 650032
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical College
WenZhou, Zhejiang, China, 325000
China
Baotou city central hospital
BaoTou, China, 014000
Baotou iron and steel group company worker hospital
BaoTou, China, 014040

Sponsors and Collaborators

Shenyang Northern Hospital

Investigators

Principal Investigator:	Yaling Han, MD	Shenyang Northern Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li J, Li Y, Wang X, Yang S, Gao C, Zhang Z, Yang C, Jing Q, Wang S, Ma Y, Wang Z, Liang Y, Han Y. Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease: insight from the TRACK-D study. Chin Med J (Engl). 2014;127(12):2332-6.

Han Y, Zhu G, Han L, Hou F, Huang W, Liu H, Gan J, Jiang T, Li X, Wang W, Ding S, Jia S, Shen W, Wang D, Sun L, Qiu J, Wang X, Li Y, Deng J, Li J, Xu K, Xu B, Mehran R, Huo Y. Short-term rosuvastatin therapy for prevention of contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease. J Am Coll Cardiol. 2014 Jan 7-14;63(1):62-70. doi: 10.1016/j.jacc.2013.09.017. Epub 2013 Sep 26.

Responsible Party:	Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00786136 History of Changes
Other Study ID Numbers:	SYNH-20081028
First Posted:	November 6, 2008
Last Update Posted:	April 10, 2013
Last Verified:	April 2013

Keywords provided by Han Yaling, MD, Shenyang Northern Hospital:

diabetes mellitus; chronic kidney disease; contrast induced acute kidney injury; angiography

Additional relevant MeSH terms:

Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Renal Insufficiency	Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors