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 because the information has not been verified recently.
Verified April 2010 by Nanjing Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01171911
First received: July 23, 2010
Last updated: July 28, 2010
Last verified: April 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171911

Contacts
Contact: Shaoliang Chen, Director +86-25-52208048 chmengx@126.com

Locations
China, Jiangsu
Nanjing First Hospital,Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shao-liang Chen, Director    +86-25-52208048    chmengx@126.com   
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Chair: Shao-liang Chen, Director Nanjing First Hospital,Nanjing Medical University
  More Information

No publications provided

Responsible Party: Shao-Liang Chen/Hospital director, Nanjing First Hospital
ClinicalTrials.gov Identifier: NCT01171911     History of Changes
Other Study ID Numbers: NJESS20103079
Study First Received: July 23, 2010
Last Updated: July 28, 2010
Health Authority: China: Ethics Committee

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Calcium Channel Blockers
Nicardipine
Esmolol
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014