Assessment of relationship between segmental coronary endothelial function and plaque progression/regressio

Not Applicable

Recruiting

• Conditions: Stable coronary artery disease patients; Cardiovascular - Coronary heart disease; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12612000594820
• Lead Sponsor: Cardiovascular Investigation Unit, Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

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)

Current atrial fibrillation or conduction system disease (first/second/third degree AV Block)

Use of inhaled salbutamol within the previous 8 hours, concomitant use of long acting beta-agonists (ie salmeterol), beta-blockers

All asthmatics

Study & Design

• Study Type: Observational
• Study Design: Not specified