Recruitment

Recruitment Status
Completed

Inclusion Criteria

≥18 years of age
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]).
...
≥18 years of age
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]).
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.

Exclusion Criteria

Bleeding diathesis
Cardiogenic shock
Known coronary artery spasm
...
Bleeding diathesis
Cardiogenic shock
Known coronary artery spasm
Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
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)

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

≥18 years of age
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]).
...
≥18 years of age
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]).
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.

Exclusion Criteria

Bleeding diathesis
Cardiogenic shock
Known coronary artery spasm
...
Bleeding diathesis
Cardiogenic shock
Known coronary artery spasm
Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
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)

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