NCT04354051

The Nitrite and Coronary Flow Study

The Vascular Effects of Nitrite on Coronary Flow Under Normoxia and Hypoxia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 baseline MRI to assess coronary flow in normoxia. Next, hypoxia will be induced using 12% oxygen/88% nitrogen. The participant will then have a baseline MRI to assess coronary flow in hypoxia (3 breath-hold image captures). After all baseline images have been captured, the investigators will commence an intravenous nitrite sodium infusion, dose 70μmol, of 5 minute duration (14μmol /min-1). At the 5th minute, the participant have a further MRI image to assess coronary flow with the intervention in normoxia (3 breath-hold image captures). A 10-minute washout will follow (with the half-life of nitrite being documented as 110 seconds). There will be optional repeat 3 breath-hold image captures at 5 minutes and at 10 minutes. Next hypoxia will be induced using 12% oxygen/88% nitrogen again. The investigators will commence a second intravenous nitrite sodium infusion, dose 70μmol, 5 minute duration (14μmol /min-1). At the 5th minute, the participant will have a further MRI image to assess coronary flow with the intervention in hypoxia (3 breath-hold image captures). At the end of the study the participant will have blood taken and this will be analysed for repeat levels of nitrate, nitrite and nitroso species. All interventions will be performed by fully trained and competent medical staff.

Conditions

• Cardiovascular Diseases
• Vasodilation
• Hypoxia

Interventions

Type	Name	Description
DRUG	Sodium Nitrite	Intravenous nitrite sodium infusion, dose 70μmol, of 5 minute duration (14μmol /min-1).

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2020-04-21
• Last updated: 2020-04-21

Locations

1 site across 1 country: United Kingdom