A Prospective Study to Evaluate the Effect of Chronic Nitrate Therapy on Vasodilation Function in Coronary Heart Disease
1 other identifier
observational
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 22, 2013
March 1, 2013
4.3 years
September 1, 2011
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
flow-mediated dilation
Endothelial function evaluated by brachial artery ultrasound imaging during reactive hyperemia.
one year
Secondary Outcomes (3)
serum superoxide dismutase (SOD) level
one year
serum malondialdehyde (MDA) level
one year
serum hypersensitive C-reactive protein (hsCRP) level
one year
Study Arms (2)
control group
placebo
nitrate group
Isosorbide Mononitrate orally 20mg twice per day.
Interventions
Eligibility Criteria
Patients with catheterization confirmed coronary artery disease.
You may qualify if:
- Individuals were considered eligible for enrollment if they had at least 1 significant de novo stenosis (reduction ≥50% of the lumen diameter) on any coronary vessel at angiography.
You may not qualify if:
- Patients with liver and renal failure with creatinine\>3 mg/dL were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
Lai J, Wu B, Sun J, Shang Y, Zhu J. Long-term isosorbide mononitrate treatment impairs endothelial function in patients with coronary artery disease. Coron Artery Dis. 2013 Nov;24(7):566-71. doi: 10.1097/MCA.0000000000000029.
PMID: 23994882DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiangtao Lai, Doctor
Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 8, 2011
Study Start
August 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 22, 2013
Record last verified: 2013-03