Clinical trial NCT01171911: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Endothelial shear stress
Calcium channel blocker
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Endothelial shear stress assessed by computational fluid dynamics
timeFrame: After four minutes
Secondary outcomes:
measure: Minimal lumen area by intravascular ultrasound
timeFrame: After four minutes
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital,Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-liang Chen, Director
role: STUDY_CHAIR
References: