ISRCTN72085021已完成未知
Investigation of the effect of dietary nitrate ingestion in stable angina
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
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
- 性别
- All
入选标准
- •1. Age between 18-80
- •2. Stable angina diagnosed on coronary angiography
- •3. Not taking any additional vitamin or food supplements
- •4. Long term use of antiplatelet agents such as aspirin, clopidogrel, or anticoagulants such as warfarin, plus a statin for a period of no less than one year
- •5. A previous history of known ischaemic heart disease, diabetes and stroke is acceptable as long as the subject’s condition is deemed stable at time of recruitment into the trial by the practitioner at time of screening
排除标准
- •1. Patients already on organic nitrate treatment (Nicorandil, ISMN, GTN)
- •2. Previous history of myocardial infarction (MI) or systolic dysfunction
- •3. Previous coronary artery bypass surgery (CABG)
- •4. Current diagnosis of or treatment for malignancy, other than nonmelanoma skin cancer
- •5. Current life threatening condition other than vascular disease that may prevent a subject completing the study
- •6. Use of an investigational device or investigational drug within 30 days or 5 half lives (whichever is the longer) preceding the first dose of study medication
- •7. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject’s unwillingness to comply with all study related procedures)
- •8. Severe acute infection, or significant trauma (burns, fractures)
- •9. Pregnancy. If there is any suggestion that a participant might be pregnant, a pregnancy test will be performed before recruitment
- •10. History of alcohol or drug abuse within the past 6 months
- •11. A history of heart failure NYHA class 24 or severe LV dysfunction LVEF<30% regardless of symptom status
- •12. Systemic autoimmune disease such as rheumatoid arthritis, connective tissue disease, or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease
- •13. Subjects who have donated > 500mls blood within 56 days prior to study medication administration
- •14. Anaemia with Hb <10g/dl, or any other known blood disorder or significant illness that may affect platelet function, and coagulation. Known essential hypertension on antihypertensive medication is not a contraindication
- •15. Any non stable dosing of ongoing medication regimens throughout the study trial
- •16. A history of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody or other chronic hepatic disorder)
- •17. Abnormal liver function due to acute or chronic liver conditions 3 x upper limit of normal at screening
- •18. Renal impairment with creatinine clearance (eGFR) of <50ml/min at screening
- •19. BMI <18.5 or > or = 40kg/m2
- •20. Any patient requiring insulin (whether they are suffering from Type 1 or Type 2 diabetes mellitus)
研究者
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