Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail plus FFR guided group | Experimental | 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). |
|
| QCA guided group | Placebo Comparator | Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cocktail | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| left ventricular function | left ventricular ejection fraction evaluated by ultrasound and MRI | 1 year |
| Seattle Angina Questionnaire scores | Seattle Angina Questionnaire scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanrong Man, MD | Contact | 86 29 84775183 | manwanrong@gmail.com | |
| Dongdong Sun, MD,Phd | Contact | 86 29 84775183 | wintersun3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongdong Sun, M.D.,Ph.D. | Air Force Military Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| C074619 | bivalirudin |
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| FFR | Device | Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). |
|
|
| QCA guided group | Device | Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). |
|
| 1 year |
| Canadian Cardiovascular Society (CCS) Functional Angina classification | Canadian Cardiovascular Society (CCS) Functional Angina classification | 1 year |
| 6-minute walk distance (6MWD) | 6-minute walk distance (6MWD) | 1 year |
| stroke | number of participants with stroke | 1 year |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |