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

NCT01171911 | Unknown Phase 4 DMC

• 1 other identifier: NJESS20103079
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Endothelial shear stress; Calcium channel blocker

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Minimal lumen area by intravascular ultrasound

  After four minutes

Interventions

Nicardipine , Esmolol DRUG

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.

Also known as: Calcium channel blocker

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital,Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Nicardipine; esmolol; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Shao-liang Chen, Director

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Shaoliang Chen, Director

CONTACT

+86-25-52208048; chmengx@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 29, 2010

Record last verified: 2010-04

Locations

CN (1)