ACTRN12612000594820
Recruiting
未知
The in vivo investigation of the relationship between segmental coronary endothelial function and atherosclerotic plaque progression/regression in patients with stable coronary artery disease.
Cardiovascular Investigation Unit, Royal Adelaide Hospital0 sites45 target enrollmentJune 1, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cardiovascular Investigation Unit, Royal Adelaide Hospital
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for this study must be greater than or equal to 18 years of age and have a clinically driven indication for a coronary angiogram. Women must be non\-lactating, not of childbearing potential.
- •Angiographic inclusion criteria:
- •For the entire coronary circulation:
- •Must have angiographic evidence of either NORMAL or NON\-CRITICAL coronary artery disease in all major coronary arteries, as defined by no lesion in a native coronary artery that has \= 30% reduction in lumen diameter by angiographic visual estimation
- •Target coronary artery:
- •The target vessel must have \< 30% reduction in lumen diameter by angiographic visual estimation, and the vessel must be large enough to accommodate the IVUS catheter.
- •A vessel may be designated as the target vessel if it has NOT undergone percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), has NOT sustained a myocardial infarction (MI), is NOT currently a candidate for percutaneous coronary intervention or a likely candidate for intervention over the next 18 months, and is NOT a bypass graft
Exclusion Criteria
- •Subjects who have symptoms consistent with moderate or greater severity of congestive heart failure (New York Heart Association (NYHA) Class III or IV), or whose recent determination of left ventricular ejection fraction (LVEF) is \< 0\.35, by contrast left ventriculography, echocardiography, or radionuclide ventriculography
- •Uncontrolled hypertension defined as a resting systolic blood pressure of greater than or equal to 180 mmHg
- •Clinically severe valvular heart disease
- •Contraindication to intracoronary GTN (hypertrophic obstructive cardiomyopathy;
- •cerebral haemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
- •Recent acute coronary syndrome (within last 4 weeks)
- •Known coronary artery spasm
- •Significant bleeding risk (ie previous haemorrhagic stroke, active peptic ulcer disease)
- •Bleeding diathesis
- •Significant renal impairment (patients will be excluded if their calculated creatinine clearance is \< 60 mL/min)
Outcomes
Primary Outcomes
Not specified
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