DRUG
cocktail
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).
Cocktail Injection Improves Outcomes of FFR Guided PCI
Status
Unknown
Phase
Phase 4
Enrollment
500
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Full 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
Treatment arms and agents.
DEVICE
FFR
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
DEVICE
QCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Timeline
From registration to results.
First posted
Oct 30, 2015
Study start
Oct 2015
Primary completion
Oct 2017
Study completion
Oct 2017
Results posted
Not reported
Registry updated
Oct 30, 2015
Outcomes
What the study measures.
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
left ventricular function
Time frame · 1 year
left ventricular ejection fraction evaluated by ultrasound and MRI
Seattle Angina Questionnaire scores
Time frame · 1 year
Seattle Angina Questionnaire scores
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time frame · 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
6-minute walk distance (6MWD)
Time frame · 1 year
6-minute walk distance (6MWD)
stroke
Time frame · 1 year
number of participants with stroke
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- 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
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Xijing hospital
Xi'an, Shaanxi, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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