This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Xijing hospital
Xi'an, Shaanxi, China
RECRUITINGMajor adverse cardiac events
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
Time frame: 1 year
left ventricular function
left ventricular ejection fraction evaluated by ultrasound and MRI
Time frame: 1 year
Seattle Angina Questionnaire scores
Seattle Angina Questionnaire scores
Time frame: 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time frame: 1 year
6-minute walk distance (6MWD)
6-minute walk distance (6MWD)
Time frame: 1 year
stroke
number of participants with stroke
Time frame: 1 year
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