Recruitment

Recruitment Status
Completed

Inclusion Criteria

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.
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)
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.
≥18 years of age

Exclusion Criteria

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

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

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.
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)
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.
≥18 years of age

Exclusion Criteria

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

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
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