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Adding resources
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Dean
@@ -1,189 +1,704 @@
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}
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]
|
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},
|
||||
"overall_official": {
|
||||
"role": "Principal Investigator",
|
||||
"affiliation": "NYU School of Medicine",
|
||||
"last_name": "Binita Shah, MD"
|
||||
},
|
||||
"overall_contact_backup": {
|
||||
"last_name": "Binita Shah, MD"
|
||||
},
|
||||
"condition_browse": {
|
||||
"mesh_term": [
|
||||
"Myocardial Infarction",
|
||||
"ST Elevation Myocardial Infarction",
|
||||
"Infarction"
|
||||
]
|
||||
},
|
||||
"overall_contact": {
|
||||
"phone": "646-501-9648",
|
||||
"last_name": "Fatmira Curovic",
|
||||
"email": "fatmira.curovic@nyumc.org"
|
||||
},
|
||||
"responsible_party": {
|
||||
"responsible_party_type": "Principal Investigator",
|
||||
"investigator_title": "Assistant Professor of Medicine",
|
||||
"investigator_full_name": "Binita Shah",
|
||||
"investigator_affiliation": "NYU Langone Health"
|
||||
},
|
||||
"study_first_submitted_qc": "March 12, 2019",
|
||||
"start_date": {
|
||||
"type": "Actual",
|
||||
"content": "March 4, 2019"
|
||||
},
|
||||
"has_expanded_access": "No",
|
||||
"study_first_posted": {
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||||
"type": "Actual",
|
||||
"content": "March 14, 2019"
|
||||
},
|
||||
"arm_group": [
|
||||
{
|
||||
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|
||||
},
|
||||
{
|
||||
"arm_group_label": "Placebo"
|
||||
}
|
||||
],
|
||||
"primary_outcome": {
|
||||
"measure": "soluble L-selectin",
|
||||
"time_frame": "between baseline and 3 months",
|
||||
"description": "Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups."
|
||||
},
|
||||
"secondary_outcome": [
|
||||
{
|
||||
"measure": "Other soluble markers of neutrophil activity",
|
||||
"time_frame": "between baseline and 3 months",
|
||||
"description": "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)"
|
||||
},
|
||||
{
|
||||
"measure": "Markers of systemic inflammation",
|
||||
"time_frame": "between baseline and 3 months",
|
||||
"description": "Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)"
|
||||
},
|
||||
{
|
||||
"measure": "Neutrophil-driven responses that may further propagate injury",
|
||||
"time_frame": "between baseline and 3 months",
|
||||
"description": "Neutrophil-driven responses that may further propagate injury will be evaluated at baseline and 3 months after STEMI (neutrophil extracellular traps, neutrophil-derived microparticles)"
|
||||
}
|
||||
],
|
||||
"oversight_info": {
|
||||
"is_fda_regulated_drug": "No",
|
||||
"is_fda_regulated_device": "No",
|
||||
"has_dmc": "No"
|
||||
},
|
||||
"last_update_posted": {
|
||||
"type": "Actual",
|
||||
"content": "September 12, 2019"
|
||||
},
|
||||
"id_info": {
|
||||
"nct_id": "NCT03874338",
|
||||
"org_study_id": "18-01323",
|
||||
"secondary_id": "1R01HL146206"
|
||||
},
|
||||
"enrollment": {
|
||||
"type": "Anticipated",
|
||||
"content": "670"
|
||||
},
|
||||
"study_first_submitted": "March 12, 2019",
|
||||
"condition": [
|
||||
"Neutrophils.Hypersegmented | Bld-Ser-Plas",
|
||||
"STEMI - ST Elevation Myocardial Infarction"
|
||||
],
|
||||
"study_type": "Observational",
|
||||
"required_header": {
|
||||
"download_date": "ClinicalTrials.gov processed this data on July 19, 2020",
|
||||
"link_text": "Link to the current ClinicalTrials.gov record.",
|
||||
"url": "https://clinicaltrials.gov/show/NCT03874338"
|
||||
},
|
||||
"last_update_submitted": "September 10, 2019",
|
||||
"completion_date": {
|
||||
"type": "Anticipated",
|
||||
"content": "February 1, 2022"
|
||||
},
|
||||
"location": {
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||||
"contact": {
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||||
"phone": "646-501-9648",
|
||||
"last_name": "Fatmira Curovic",
|
||||
"email": "fatmira.curovic@nyumc.org"
|
||||
},
|
||||
"facility": {
|
||||
"address": {
|
||||
"zip": "10016",
|
||||
"country": "United States",
|
||||
"city": "New York",
|
||||
"state": "New York"
|
||||
},
|
||||
"name": "NYU School of Medicine"
|
||||
},
|
||||
"status": "Recruiting",
|
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"contact_backup": {
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"last_name": "Binita Shah, MD"
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}
|
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},
|
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"intervention": {
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"intervention_type": "Drug",
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"arm_group_label": [
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||||
"Colchicine",
|
||||
"Placebo"
|
||||
],
|
||||
"description": "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.",
|
||||
"intervention_name": "Colchicine Pill"
|
||||
},
|
||||
"patient_data": {
|
||||
"sharing_ipd": "No"
|
||||
},
|
||||
"verification_date": "September 2019"
|
||||
}
|
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"profile": {
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"tz": "Africa/Cairo",
|
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"elevFT": 75
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}
|
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}
|
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]
|
||||
}
|
||||
Reference in New Issue
Block a user