适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The subject is at least 21 years of age.
- •2. The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery (left main, left anterior descending coronary artery and/or left circumflex artery or branches of these vessels) anticipated to utilize at least 50 mL of iodinated contrast media (on the basis of a prior angiogram or pending angiographic confirmation).
- •3. The subject has documented CKD and an estimated eGFR > 20 and * 40 mL/min/1.73 m2 (as determined by the MDRD equation) ; or
- •an eGFR> 40 and < 60 mL/min/1.73 m2 and one or more of the following co-morbidities: stage III/IV congestive heart failure (as defined by NYHA criteria), diabetes mellitus, or 75 years of age or greater.
- •4. The subject (or subject*s legal representative) is willing and able to provide appropriate informed consent.
- •5. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
排除标准
- •1. The subject is currently undergoing renal dialysis.
- •2. The subject is in acute renal failure or has unstable renal function based on clinical findings and/or a known change in serum creatinine of * 0.5mg/dL or * 25% within 7 days prior to enrollment compared to the last serum creatinine measurement on record. If the serum creatinine has risen to this degree, then at least 2 serum creatinine measures drawn >48 hours but <7 days all within 0.5mg/dL must be present for a new baseline to be established.
- •3. The subject has received contrast media within 7 days prior to the procedure day or a second imaging study of any type which will require iodinated contrast is planned within the 30 days following the protocol-defined procedure.
- •4. The subject is expected to undergo any of the following: ventriculography, aortography, renal angiography, or any other injection of >10 cc of contrast in total other than coronary angiography or PCI as described below.
- •5. The subject has a known allergy to iodine-based contrast agents that cannot be adequately pre-medicated (patients with a history of true anaphylaxis may not be enrolled).
- •6. The subject requires one or more of the following nephrotoxic agents: Aminoglycoside antibiotics, Sulfonamides, Amphotericin B, Levofloxacin, Ciprofloxacin, Rifampin, Tetracycline, Intravenous Acyclovir, Pentamidine, Penicillin and Cephalosporins, Cisplatin, Methotrexate, Mitomycin, Cyclosporine, Tacrolimus.
- •7. The subject has a known bleeding diathesis (e.g. thrombocytopenia [<100,000 cells/mm3], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal bleeding gross genitourinary bleeding).
- •8. The subject is currently on intravenous heparin that cannot be discontinued at least 4 hours before the procedure, intravenous bivalirudin that cannot be discontinued at least 4 hours before the procedure, intravenous abciximab that cannot be discontinued at least 24 hours before the procedure, intravenous tirofiban or eptifibatide that cannot be discontinued at least 6 hours before the procedure, or has received any low molecular weight heparin within 12 hours or factor Xa antagonist (including fondaparinux) within 24 hours.
- •9. The subject has a known hypersensitivity to both heparin and bivalirudin or aspirin or all thienopyridine agents or iodinated contrast that cannot be adequately pre-medicated.
- •10. The subject is hypotensive (systolic blood pressure < 90 mmHg not corrected by intravenous saline) or requiring intravenous pressors and/or intra-aortic balloon counterpulsation.
- •11. The subject has decompensated heart failure requiring intravenous diuretic, inotropic, vasopressor or intraaortic balloon support in the previous 7 days.
- •12. The subject has had recent (within last 72 hours) acute myocardial infarction as defined in the *Universal Definition of Myocardial Infarction*:
- •a. Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following
- •i. Symptoms of ischemia
- •ii. ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block)
- •iii. Development of pathological Q waves in the ECG
- •iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
- •13. The subject has undergone previous procedures involving
研究者
相似试验
招募中
不适用
PRECIOUS trialJPRN-UMIN000021514Aichi cancer center hospital370
已完成
不适用
DEFENSE TrialSubjects indicated for ICD or CRT-D.JPRN-UMIN000007212Medtronic Japan Co., Ltd151
已完成
不适用
Trial NL77761.056.21Publication withdrawn by sponsorNL-OMON51945CB Pharma24
已完成
1 期
Phase 1 Trial: FortreaHealthy volunteersISRCTN40371122JAZZ Pharmaceuticals Research UK Ltd96
招募中
4 期
PROSPECTIVE, RANDOMIZED TRIAL OF TICAGRELOR VERSUS PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROMEI20.0I21I24.9Acute ischaemic heart disease, unspecifiedUnstable anginaAcute myocardial infarctionDRKS00005441Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen4,000