ORBITA-CTO Pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.
Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.
Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
Change in angina symptom ordinal scale score between groups
Change in angina symptom ordinal scale score between groups
Time frame: 24 & 26 weeks
Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
Time frame: 24 & 26 weeks
SAQ summary score
SAQ summary score
Time frame: 24 & 26 weeks
Quality of life as measured by EQ-5D-5L
Quality of life as measured by EQ-5D-5L
Time frame: 24 & 26 weeks
Change in Rose dyspnea scale
Change in Rose dyspnea scale
Time frame: 24 & 26 weeks
Change in peak VO2 and VO2 at AT
Change in peak VO2 and VO2 at AT
Time frame: 24 weeks
Fidelity of blinding using Bang's blinding index (BI)
Fidelity of blinding using Bang's blinding index (BI)
Time frame: 24 weeks
Protocol adherence
Proportion of participants adherent to allocated randomised treatment
Time frame: 26 weeks
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