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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Nanjing Medical University.
Recruitment status was:  Not yet recruiting
Information provided by:
Nanjing Medical University Identifier:
First received: July 23, 2010
Last updated: July 28, 2010
Last verified: April 2010

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.

Condition Intervention Phase
Acute Coronary Syndrome Coronary Artery Disease Drug: Nicardipine , Esmolol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nanjing First Hospital, Nanjing Medical University

Resource links provided by NLM:

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Endothelial shear stress assessed by computational fluid dynamics [ Time Frame: 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:
  • Minimal lumen area by intravascular ultrasound [ Time Frame: 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.

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Calcium channel blocker
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01171911

Contact: Shaoliang Chen, Director +86-25-52208048

China, Jiangsu
Nanjing First Hospital,Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shao-liang Chen, Director    +86-25-52208048   
Sponsors and Collaborators
Nanjing Medical University
Study Chair: Shao-liang Chen, Director Nanjing First Hospital, Nanjing Medical University
  More Information

Responsible Party: Shao-Liang Chen/Hospital director, Nanjing First Hospital Identifier: NCT01171911     History of Changes
Other Study ID Numbers: NJESS20103079
Study First Received: July 23, 2010
Last Updated: July 28, 2010

Keywords provided by Nanjing Medical University:
Endothelial shear stress
Calcium channel blocker

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Calcium, Dietary
Calcium Channel Blockers
Bone Density Conservation Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators
Antihypertensive Agents
Vasodilator Agents processed this record on September 21, 2017