Protocol Progress: 34 patients met eligibility criteria for this protocol and were consented. There have been two drop-outs from the study; one because of unwillingness to continue with diet and the second because of chest pain on the morning of testing, reported to the IRB as an SAE (both reported at the 2005 continuing review). In all others, compliance with diet was highly satisfactory and measurements were performed as stipulated in the protocol. ? ? Reasons for Continuation of Protocol: We have permission to enroll 42 patients into this protocol in order to achieve 36 analyzable studies and we expect to achieve full enrollment during the coming year. The hypothesis posed in this study remains important, as the determination of dietary sources of NO may have important implications in the management of patients with atherosclerotic cardiovascular disease.
Cosby, Kenyatta; Partovi, Kristine S; Crawford, Jack H et al. (2003) Nitrite reduction to nitric oxide by deoxyhemoglobin vasodilates the human circulation. Nat Med 9:1498-505 |
Schechter, Alan N; Gladwin, Mark T; Cannon 3rd, Richard O (2002) NO solutions? J Clin Invest 109:1149-51 |