Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01430780
Status:
UNKNOWN
Last Update Posted:
2013-03-22
First Post:
2011-09-01
Brief Title:
A Prospective Study to Evaluate the Effect of Chronic Nitrate Therapy on Vasodilation Function in Coronary Heart Disease
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
A Prospective Study to Evaluate the Influence of Oxygen Free Radical Injury Induced by Long-term Nitrates Therapy on Vasodilation Function of Patients With Coronary Heart Disease
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Basic studies has showed that sustained use of nitrates might associated with adverse effects on vascular function mediated by an increase in nitrate-induced oxidative stress But it remains unclear whether oxidative stress increases with endothelial function impairment in patients with coronary artery disease CAD during administration of long-term oral nitrates The investigators evaluated whether administration of long-term isosorbide mononitrate ISMN treatment was associated with oxidative stress increase and endothelial function impairment in patients with CAD
Detailed Description:
Organic nitrates are widely prescribed for the treatment of angina pectoris in patients with coronary artery disease CAD In China many patients with CAD are prescribed nitrates as a long-term treatment The most commonly prescribed nitrates for long-time treatment is isosorbide mononitrate ISMN The reason for their use is that the majority of physicians believe chronic therapy with organic nitrates is associated with an improvement in symptoms and has neutral or potentially beneficial effects on long-term patient outcome although this assumption remains unproven
Recently multiple lines of evidence documented that sustained use of nitrates was associated with adverse effects on vascular function which appeared to be mediated by an increase in nitrate-induced oxidative stress The accumulation of oxygen free radicals during chronic nitrate therapy was associated with endothelial dysfunction increased arterial sensitivity to vasoconstrictors and the development of abnormalities in a number of important enzymes involved in the regulation of vascular homeostasis including the superoxide dismutase protein kinase C matrix metalloproteinases and prostaglandin synthase This may lead to development of nitrate tolerance endothelial dysfunction Furthermore endothelial dysfunction is a risk factor for worse prognosis of patients with CAD
Up to date some clinical research focus on how to prevent tolerance and clinical outcome of nitrate therapy were involved short follow-up periods of only a few weeks It is too short to assess the true clinical impact of nitrate-induced endothelial dysfunction and the safety of long-term nitrate therapy requires systematic review So prospective randomized study with longer treatment period is needed to observe the chronic impact of nitrate therapy on endothelial function
Therefore the investigators prospectively investigated whether long-term ISMN therapy had any influence on endothelial function evaluated by brachial artery ultrasound imaging during reactive hyperemia in patients with catheterization confirmed CAD and whether this was associated with increased oxidization or inflammation burden
Recently multiple lines of evidence documented that sustained use of nitrates was associated with adverse effects on vascular function which appeared to be mediated by an increase in nitrate-induced oxidative stress The accumulation of oxygen free radicals during chronic nitrate therapy was associated with endothelial dysfunction increased arterial sensitivity to vasoconstrictors and the development of abnormalities in a number of important enzymes involved in the regulation of vascular homeostasis including the superoxide dismutase protein kinase C matrix metalloproteinases and prostaglandin synthase This may lead to development of nitrate tolerance endothelial dysfunction Furthermore endothelial dysfunction is a risk factor for worse prognosis of patients with CAD
Up to date some clinical research focus on how to prevent tolerance and clinical outcome of nitrate therapy were involved short follow-up periods of only a few weeks It is too short to assess the true clinical impact of nitrate-induced endothelial dysfunction and the safety of long-term nitrate therapy requires systematic review So prospective randomized study with longer treatment period is needed to observe the chronic impact of nitrate therapy on endothelial function
Therefore the investigators prospectively investigated whether long-term ISMN therapy had any influence on endothelial function evaluated by brachial artery ultrasound imaging during reactive hyperemia in patients with catheterization confirmed CAD and whether this was associated with increased oxidization or inflammation burden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None