Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery

Phase 4

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease

• Registration Number: NCT01171911
• Lead Sponsor: Nanjing Medical University

Brief Summary

Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.

The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.

Detailed Description

Blood flow-induced endothelial shear stress has strong effect on endothelial function and development or progression of plaque formation. It is extensively accepted that low and/or oscillating shear stress causes endothelial dysfunction and is one of crucial factors in localizing early atherosclerosis .In contrary, normal and high shear stress is atheroma protective and is involved in compensatory remodeling . Most studies reported that the endothelial shear stress distribution in often idealized geometrical models of human coronary arteries was the subject of numerous investigations , and in these studies it was shown that the geometry of coronary arteries is the main determinant of the observed shear stress distribution. Generally, downstream of a plaque, low shear stress can be expected, Several cardiovascular active drugs have been shown to be cardio-protective for patients with obstructive coronary disease. Of these drugs, calcium channel blocker is one of most prescribed in everyday clinical practice. Ninomiya et al. reported calcium channel blocker was associated with increased coronary diameter and blood fluid with dose-dependent pattern in patients with normal or mild stenotic coronary artery. However, no reports on the dynamic change of endothelial shear stress after calcium channel blocker in -vitron were published so far. As a result, the aim of this study was to evaluate the effect of intra-venous injection of Nicardipine, one calcium channel blocker with shorter half-time, on the re-distribution of endothelial shear stress in patients with acute coronary syndrome and mild stenotic (\<50%) coronary artery disease.

Study Timeline

• Status Verified: 2010-04
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-28
• Last Update Submitted: 2010-07-28
• Study First Posted: 2010-07-29
• Last Update Posted: 2010-07-29
• Study Start: 2010-10
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of unstable angina and non-Q wave myocardial infarction
• Age 18-75 yr.
• Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation
• Blood pressure >110/70 mmHg
• Heart rate 60-~100 bpm, No cardiac arrhythmias

Exclusion Criteria

• St-elevation myocardial infarction
• Lower blood pressure(<100/70mmHg)
• Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias
• Allergy to study drugs
• Women in pregnancy
• Liver dysfunction
• Creatinine >2.5mg/dl
• Bleeding stroke within 6 months
• Left ventricular ejection fraction<30% before maximal medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial shear stress assessed by computational fluid dynamics	After four minutes	At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.

Secondary Outcome Measures

Name	Time	Method
Minimal lumen area by intravascular ultrasound	After four minutes	At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.

Trial Locations

Locations (1)

Nanjing First Hospital,Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China