Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
TRACK-D
Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
1 other identifier
interventional
2,998
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus
Started Dec 2008
Typical duration for phase_4 diabetes-mellitus
53 active sites
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
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedApril 10, 2013
April 1, 2013
2.8 years
November 5, 2008
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
72 h
Secondary Outcomes (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.
30 d
Study Arms (2)
1
EXPERIMENTALperioperative rosuvastatin administration for at least 5 dosages
control
PLACEBO COMPARATORblank control of perioperative statin administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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％)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
The Armed Police General Hospital
Beijing, Beijing Municipality, 100000, China
The Chinese people's liberation army general hospital affiliated hospitals
Beijing, Beijing Municipality, 100000, China
Peking University first hospital
Beijing, Beijing Municipality, 100034, China
General Hospital Of The Second Artillery Force of the PLA
Beijing, Beijing Municipality, 100088, China
The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
Beijing, Beijing Municipality, 100853, China
The Third Military Medical University, Chongqing Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Dongguan Kanghua Hospital
Dongguan, Guangdong, 523080, China
General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, 510010, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
Chinese People's Liberation Army 252th Hostipal
Baoding, Hebei, 610000, China
CanZhou Central Hospital
Cangzhou, Hebei, 610001, China
Shijiazhuang International Peace Hospital
Shijiazhuang, Hebei, 600082, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
HeNan Provincial People's Hospital
Zhengzhou, Henan, China
WuHan Asia Heart Hosital
Wuhan, Hubei, 430022, China
WuHan Union Hospital Of China
Wuhan, Hubei, 430022, China
TongJi Medical College HuaZhong University Of Science & Technology
Wuhan, Hubei, 430030, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, 430060, China
Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
Wuhan, Hubei, 430070, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
NanJing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
Changchun, Jilin, 130011, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Changchun Central Hospital
Changchun, Jilin, 130051, China
General Hospital of Liaoning Anshan Iron and Steel Group Corporation
Anshan, Liaoning, 114001, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
Fushun central hospital
Fushun, Liaoning, 113006, China
The First Affiliated Hospital of Liaoning Medical College
Jinzhou, Liaoning, 121001, China
ShenZhou Hopital Of ShenYang Medical College
ShengYang, Liaoning, 110032, China
PLA 202 Hospital
Shenyang, Liaoning, 110004, China
Shenyang Nortern Hospital
Shenyang, Liaoning, 110016, China
Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
Shenyang, Liaoning, 110032, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032, China
The 463th Hospital Of PLA
Shenyang, Liaoning, 110042, China
Affiliated Hospital of Ningxia Medical College
Yinchuan, Ningxia, 750004, China
General Hospital of Jinan Military Area Command of Chinese PLA
Jinan, Shandong, 250031, China
88th Hospital of the Chinese PLA
TaiAn, Shandong, 271000, China
Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025, China
Xijing Hospital of the Fourth Military Medical University
XiAn, Shanxi, 710032, China
Chengdu Military General Hospital
Chengdu, Sichuan, 610083, China
PLA 254 Hosipital
Tianjin, Tianjin Municipality, 300142, China
Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
Tianjin, Tianjin Municipality, 300162, China
WuluMuqi General Hospital of PLA Lanzhou Military Area Command
Ürümqi, Xinjiang, 830000, China
The First Affilliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650031, China
Kunming General Hospital of PLA
Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Baotou city central hospital
Baotou, 014000, China
Baotou iron and steel group company worker hospital
Baotou, 014040, China
Related Publications (2)
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.
PMID: 24931252DERIVEDHan 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.
PMID: 24076297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaling Han, MD
Shenyang Northern Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
December 1, 2008
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
April 10, 2013
Record last verified: 2013-04