The Nitrite and Coronary Flow Study

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of East Anglia
• Collaborator: Royal Brompton & Harefield NHS Foundation Trust

Criteria

Inclusion Criteria:

1. Male or female, aged greater than or equal to 18 years

2. Not known to have any significant past medical history and not having regular follow up

3. Able to provide informed consent

Exclusion Criteria:

1. 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.

2. Known allergy or intolerance to Nitrites

3. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency detected at screening in males of African, Asian or Mediterranean decent

4. 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

5. 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

6. Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease

7. Any contra-indication to MRI, including the presence of an implanted metal device or suspected metal foreign bodies