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

Primary Purpose

Diabetes Mellitus, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring diabetes mellitus, chronic kidney disease, contrast induced acute kidney injury, angiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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％)

Sites / Locations

  • The Armed Police General Hospital
  • The Chinese people's liberation army general hospital affiliated hospitals
  • Peking University first hospital
  • General Hospital Of The Second Artillery Force of the PLA
  • The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
  • The Third Military Medical University, Chongqing Xinqiao Hospital
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • First Hospital of Lanzhou University
  • Dongguan Kanghua Hospital
  • General Hospital of Guangzhou Military Command of PLA
  • The First Affiliated Hospital of Guangzhou Medical College
  • Chinese People's Liberation Army 252th Hostipal
  • CanZhou Central Hospital
  • Shijiazhuang International Peace Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The Second Affiliated Hospital of Harbin Medical University
  • HeNan Provincial People's Hospital
  • WuHan Asia Heart Hosital
  • WuHan Union Hospital Of China
  • TongJi Medical College HuaZhong University Of Science & Technology
  • Renmin Hospital Of Wuhan University
  • Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
  • Nanjing First Hospital
  • NanJing Drum Tower Hospital
  • FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
  • The First Hospital of Jilin University
  • The Second Hospital of Jilin University
  • Changchun Central Hospital
  • General Hospital of Liaoning Anshan Iron and Steel Group Corporation
  • Affiliated Zhongshan Hospital of Dalian University
  • Fushun central hospital
  • The First Affiliated Hospital of Liaoning Medical College
  • ShenZhou Hopital Of ShenYang Medical College
  • PLA 202 Hospital
  • Shenyang Nortern Hospital
  • Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
  • The Fourth Affiliated Hospital of China Medical University
  • The 463th Hospital Of PLA
  • Affiliated Hospital of Ningxia Medical College
  • General Hospital of Jinan Military Area Command of Chinese PLA
  • 88th Hospital of the Chinese PLA
  • Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
  • Xijing Hospital of the Fourth Military Medical University
  • Chengdu Military General Hospital
  • PLA 254 Hosipital
  • Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
  • WuluMuqi General Hospital of PLA Lanzhou Military Area Command
  • The First Affilliated Hospital Of Xinjiang Medical University
  • The First Affiliated Hospital of Kunming Medical College
  • Kunming General Hospital of PLA
  • The First Affiliated Hospital of Wenzhou Medical College
  • Baotou city central hospital
  • Baotou iron and steel group company worker hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

control

Arm Description

perioperative rosuvastatin administration for at least 5 dosages

blank control of perioperative statin administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 5, 2008
Last Updated
April 9, 2013
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00786136
Brief Title
Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
Acronym
TRACK-D
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Chronic Kidney Disease
Keywords
diabetes mellitus, chronic kidney disease, contrast induced acute kidney injury, angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2998 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
perioperative rosuvastatin administration for at least 5 dosages
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
blank control of perioperative statin administration
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Intervention Description
rosuvastatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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％)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Armed Police General Hospital
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The Chinese people's liberation army general hospital affiliated hospitals
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking University first hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
General Hospital Of The Second Artillery Force of the PLA
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Third Military Medical University, Chongqing Xinqiao Hospital
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
First Hospital of Lanzhou University
City
LanZhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Dongguan Kanghua Hospital
City
DongGuan
State/Province
Guangdong
ZIP/Postal Code
523080
Country
China
Facility Name
General Hospital of Guangzhou Military Command of PLA
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Chinese People's Liberation Army 252th Hostipal
City
BaoDing
State/Province
Hebei
ZIP/Postal Code
610000
Country
China
Facility Name
CanZhou Central Hospital
City
CangZhou
State/Province
Hebei
ZIP/Postal Code
610001
Country
China
Facility Name
Shijiazhuang International Peace Hospital
City
ShiJiaZhuang
State/Province
Hebei
ZIP/Postal Code
600082
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
HeNan Provincial People's Hospital
City
ZhengZhou
State/Province
Henan
Country
China
Facility Name
WuHan Asia Heart Hosital
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
WuHan Union Hospital Of China
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
TongJi Medical College HuaZhong University Of Science & Technology
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital Of Wuhan University
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Nanjing First Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
NanJing Drum Tower Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
City
ChangChun
State/Province
Jilin
ZIP/Postal Code
130011
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Changchun Central Hospital
City
ChangChun
State/Province
Jilin
ZIP/Postal Code
130051
Country
China
Facility Name
General Hospital of Liaoning Anshan Iron and Steel Group Corporation
City
AnShan
State/Province
Liaoning
ZIP/Postal Code
114001
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
DaLian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
Fushun central hospital
City
FuShun
State/Province
Liaoning
ZIP/Postal Code
113006
Country
China
Facility Name
The First Affiliated Hospital of Liaoning Medical College
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121001
Country
China
Facility Name
ShenZhou Hopital Of ShenYang Medical College
City
ShengYang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
PLA 202 Hospital
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Shenyang Nortern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
The Fourth Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
The 463th Hospital Of PLA
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Affiliated Hospital of Ningxia Medical College
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
General Hospital of Jinan Military Area Command of Chinese PLA
City
JiNan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
88th Hospital of the Chinese PLA
City
TaiAn
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Xijing Hospital of the Fourth Military Medical University
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Chengdu Military General Hospital
City
ChengDu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
Facility Name
PLA 254 Hosipital
City
TianJin
State/Province
Tianjin
ZIP/Postal Code
300142
Country
China
Facility Name
Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
City
TianJin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China
Facility Name
WuluMuqi General Hospital of PLA Lanzhou Military Area Command
City
WuLuMuQI
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
The First Affilliated Hospital Of Xinjiang Medical University
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical College
City
KunMing
State/Province
Yunnan
ZIP/Postal Code
650031
Country
China
Facility Name
Kunming General Hospital of PLA
City
KunMing
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
WenZhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Baotou city central hospital
City
BaoTou
ZIP/Postal Code
014000
Country
China
Facility Name
Baotou iron and steel group company worker hospital
City
BaoTou
ZIP/Postal Code
014040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24931252
Citation
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.
Results Reference
derived
PubMed Identifier
24076297
Citation
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.
Results Reference
derived

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Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

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