Recruitment

Recruitment Status
Completed

Inclusion Criterias

Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
Target artery must be >2 mm to accommodate the IVUS catheter.
...
Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
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)

Exclusion Criterias

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

Summary

Conditions
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 Criterias

Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
Target artery must be >2 mm to accommodate the IVUS catheter.
...
Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
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)

Exclusion Criterias

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

Locations

Adelaide, South Australia, 5000
Adelaide, South Australia, 5000

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