Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)
This study has been completed.
Sponsor:
Shenyang Northern Hospital
Information provided by (Responsible Party):
Han Yaling, MD, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT00786136
First received: November 5, 2008
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Chronic Kidney Disease |
Drug: rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Shenyang Northern Hospital:
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 [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 30 d ] [ Designated as safety issue: Yes ]
| Enrollment: | 2998 |
| Study Start Date: | December 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00786136
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00786136
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Han Yaling, MD, vice president, Shenyang Northern Hospital |
| ClinicalTrials.gov Identifier: | NCT00786136 History of Changes |
| Other Study ID Numbers: | SYNH-20081028 |
| Study First Received: | November 5, 2008 |
| Last Updated: | April 9, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by 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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 30, 2016