Investigating the effects of dietary nitrate in patients with stable angina
- Conditions
- Topic: Cardiovascular diseaseSubtopic: Cardiovascular (all Subtopics)Disease: Cardiovascular PreventionCirculatory SystemCardiovascular disease prevention
- Registration Number
- ISRCTN17373946
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27998900 (added 10/04/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 246
1. Aged between 18 and 85
2. Able and willing to provide informed consent
3. Patients undergoing successful PCI procedure
4. Patients with stable angina diagnosed by a cardiologist on optimal medical therapy, undergoing an angioplasty to treat residual symptoms
1. Unstable ischaemic heart disease, with an episode of chest pain less than 24 hours
2. In patients who have had previous coronary artery bypass surgery (CABG), if they are undergoing angioplasty within a non-native vessel
3. Patients undergoing angioplasty with a bio-absorbable stent
4. Current diagnosis of or treatment for malignancy, other than nonmelanoma skin cancer
5. Current lifethreatening 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 (tested by urine HcG measurement)
10. History of alcohol or drug abuse within the past 6 months
11. A history of heart failure NYHA class 34 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. Patients 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
15. A history of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody or other chronic hepatic disorder) or HIV
16. Abnormal liver function due to acute or chronic liver conditions 3 x upper limit of normal at screening
17. Renal impairment with creatinine clearance (eGFR) of 30ml/min at screening
18. If patients are on mouthwash, they must be willing to stop using this at least 1 week before the start of the study and throughout the duration that they are involved within the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate-lumen loss within the stent is measured using optical coherence tomography (OCT) at 6 months.
- Secondary Outcome Measures
Name Time Method <br> 1. Improvement in endothelial function assessed by flow-mediated dilatation of the brachial artery at baseline and 6 months<br> 2. Reduction in target vessel revascularisation (TVR), restenosis rate (diameter >50%) and in-segment late loss is measured using angiography at 6 months (+/- 1 month)<br> 3. Reduction in major adverse cardiac events (i.e. MI, death, CVA, TVR) is measured using via a telephone call at 6, 12 and 24 months<br> 4. Reduction in plaque size as assessed using OCT at 6 months (+/- 1 month)<br> 5. Reduction in inflammatory markers and changes in plasma xanthine oxidase activity, hsCRP and IL-6 is measured using ELISAs at baseline, 6 and 12 months<br> 6. Reduction in platelet count is measured using a blood test at baseline, 6 months and 12 months<br>