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

Coronary Artery Disease Clinical Trial

Official title:

Nanjing First Hospital, Nanjing Medical University

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01171911
• Other study ID #: NJESS20103079
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 23, 2010
• Last updated: July 28, 2010
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Nanjing Medical University
• Contact: Shaoliang Chen, Director
• Phone: +86-25-52208048
• Email: chmengx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Nicardipine , Esmolol
A loading dose of Nicardipine 10mg was at a bolus injected through vein , then continuous trans-venous titration at a speed 1ug/kg was kept. A loading dose of Esmolol 0.5mg/kg/min was at a bolus injected through vein , then continuous trans-venous titration at a speed 0.2mg/kg/min was kept.

Locations

Country	Name	City	State
China	Nanjing First Hospital,Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial shear stress assessed by computational fluid dynamics	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.	After four minutes	Yes
Secondary	Minimal lumen area by intravascular ultrasound	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.	After four minutes	Yes