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

Primary Purpose

Acute Coronary Syndrome, Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nicardipine , Esmolol
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Endothelial shear stress, Calcium channel blocker

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing First Hospital,Nanjing Medical University

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 23, 2010
Last Updated
July 28, 2010
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01171911
Brief Title
Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery
Official Title
Nanjing First Hospital, Nanjing Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Coronary Artery Disease
Keywords
Endothelial shear stress, Calcium channel blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nicardipine , Esmolol
Other Intervention Name(s)
Calcium channel blocker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endothelial shear stress assessed by computational fluid dynamics
Description
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.
Time Frame
After four minutes
Secondary Outcome Measure Information:
Title
Minimal lumen area by intravascular ultrasound
Description
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.
Time Frame
After four minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoliang Chen, Director
Phone
+86-25-52208048
Email
chmengx@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-liang Chen, Director
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital,Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-liang Chen, Director
Phone
+86-25-52208048
Email
chmengx@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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