Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events
Study Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with a clinical diagnosis of recent ACS within 5 days
Exclusion Criteria
- •haemodynamic instability
- •intolerance to anti-platelet drugs
- •ineligible for coronary revascularization
- •a treatment plan for non-coronary heart surgery (e.g. valve surgery)
- •a history of prior PCI or CABG
- •angiographic evidence of severe (e.g. diffuse calcification) or mild (<30% severity) coronary disease
- •a life expectancy less than 1 year
- •adenosine allergy
Arms & Interventions
Cocktail plus FFR guided group
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).
Intervention: cocktail (Drug)
Cocktail plus FFR guided group
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).
Intervention: FFR (Device)
QCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Intervention: QCA guided group (Device)
Outcomes
Primary Outcomes
Major adverse cardiac events
Time Frame: 1 year
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
Secondary Outcomes
- stroke(1 year)
- Seattle Angina Questionnaire scores(1 year)
- left ventricular function(1 year)
- Canadian Cardiovascular Society (CCS) Functional Angina classification(1 year)
- 6-minute walk distance (6MWD)(1 year)
Investigators
sunddong
Principal Investigator
Xijing Hospital