Acute Coronary Syndromes
Conditions
Keywords
Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention
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.
Interventions
DRUGcocktail
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).
DEVICEFFR
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
DEVICEQCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 1 year | number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular function | 1 year | left ventricular ejection fraction evaluated by ultrasound and MRI |
| Seattle Angina Questionnaire scores | 1 year | Seattle Angina Questionnaire scores |
| Canadian Cardiovascular Society (CCS) Functional Angina classification | 1 year | Canadian Cardiovascular Society (CCS) Functional Angina classification |
| 6-minute walk distance (6MWD) | 1 year | 6-minute walk distance (6MWD) |
| stroke | 1 year | number of participants with stroke |
Countries
China
Contacts
Primary ContactWanrong Man, MD
Backup ContactDongdong Sun, MD,Phd
Outcome results
None listed