Recruitment

Recruitment Status
Completed

Inclusion Criteria

Target artery must be >2 mm to accommodate the IVUS catheter.
≥18 years of age
IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
...
Target artery must be >2 mm to accommodate the IVUS catheter.
≥18 years of age
IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).

Exclusion Criteria

Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
Cardiogenic shock
...
Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
Cardiogenic shock
Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
Bleeding diathesis
Known coronary artery spasm

Summary

Conditions
  • Coronary (Artery) Disease
  • Coronary Artery Disease
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Target artery must be >2 mm to accommodate the IVUS catheter.
≥18 years of age
IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
...
Target artery must be >2 mm to accommodate the IVUS catheter.
≥18 years of age
IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).

Exclusion Criteria

Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
Cardiogenic shock
...
Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
Cardiogenic shock
Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
Bleeding diathesis
Known coronary artery spasm

Tracking Information

NCT #
NCT02154295
Collaborators
  • South Australian Health and Medical Research Institute
  • Royal Adelaide Hospital
Investigators
  • Principal Investigator: Samuel Sidharta, MBBS BMedSc Royal Adelaide Hospital
  • Samuel Sidharta, MBBS BMedSc Royal Adelaide Hospital