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

NCT ID: NCT01171911

Last Updated: 2010-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-12-31

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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Endothelial shear stress; Calcium channel blocker

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Calcium channel blocker

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nanjing First Hospital

Principal Investigators

Shao-liang Chen, Director

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital,Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Shaoliang Chen, Director

Role: CONTACT

Phone: +86-25-52208048

Email: chmengx@126.com

Facility Contacts

Shao-liang Chen, Director

Role: primary

Other Identifiers

NJESS20103079

Identifier Type: -

Identifier Source: org_study_id