Neutrophils.Hypersegmented | Bld-Ser-Plas, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
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: 1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and; 2. Examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders. 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: 1. Assess the effect of colchicine on neutrophil activation in response to STEMI. 2. Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders. 3. Explore the derivation of a risk score that includes markers of neutrophil activity and is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of colchicine on the relation between this risk score and MACE.
Interventions
DRUGColchicine Pill
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.
Sponsors
Population Health Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
NYU Langone Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Use of anti-inflammatory agents (except aspirin) * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| soluble L-selectin | between baseline and 3 months | Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other soluble markers of neutrophil activity | between baseline and 3 months | 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) |
| Markers of systemic inflammation | between baseline and 3 months | Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β) |
| Neutrophil-driven responses that may further propagate injury | between baseline and 3 months | Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles) |
Countries
United States
Outcome results
None listed