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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL146206 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:
Participants undergo a blood draw at baseline and 3 months follow-up as part of the main trial, and participants who also participate in this sub study will have an additional 2 tablespoons of blood drawn.
The sub study objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine |
| ||
| Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Pill | Drug | Participants in the main CLEAR SYNERGY trial are randomized to colchicine/spironolactone versus placebo in a 2x2 factorial design. The substudy is interested in the evaluation of biospecimens obtained from patients in the colchicine vs placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| soluble L-selectin | Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups. | between baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Other soluble markers of neutrophil activity | Other markers of neutrophil activity will be evaluated at baseline and 3 months after STEMI (myeloperoxidase, matrix metalloproteinase-9, neutrophil gelatinase-associated lipocalin, neutrophil elastase, intercellular/vascular cellular adhesion molecules) | between baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial will be eligible for participation in this Neutrophil biomarker substudy. These are patients who present with STEMI.
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| Name | Affiliation | Role |
|---|---|---|
| Binita Shah, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Markers of systemic inflammation |
Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β) |
| between baseline and 3 months |
| Neutrophil-driven responses that may further propagate injury | Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles) | between baseline and 3 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |