Status:
COMPLETED
The Nitrite and Coronary Flow Study
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Cardiovascular Diseases
Vasodilation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a pharmacodynamic proof of concept study investigating the physiological effects of systemic infusion of nitrite on coronary blood flow using MRI.
Detailed Description
This is a healthy volunteer, proof of concept study. The participant will have blood taken and this will be analysed for baseline levels of nitrate, nitrite and nitroso species. They will then have a...
Eligibility Criteria
Inclusion
- Male or female, aged greater than or equal to 18 years
- Not known to have any significant past medical history and not having regular follow up
- Able to provide informed consent
Exclusion
- Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
- Known allergy or intolerance to Nitrites
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency detected at screening in males of African, Asian or Mediterranean decent
- Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH\>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
- Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer
- Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease
- Any contra-indication to MRI, including the presence of an implanted metal device or suspected metal foreign bodies
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04354051
Start Date
July 1 2018
End Date
December 1 2018
Last Update
April 21 2020
Active Locations (1)
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1
University of East Anglia
Norwich, Norfolk, United Kingdom, NR4 7TJ