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Dean 2022-10-07 10:35:14 +01:00
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"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": {
"type": "Actual",
"content": "March 14, 2019"
},
"arm_group": [
{
"arm_group_label": "Colchicine"
},
{
"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": {
"contact": {
"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",
"contact_backup": {
"last_name": "Binita Shah, MD"
}
},
"intervention": {
"intervention_type": "Drug",
"arm_group_label": [
"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"
}
"profile": {
"tz": "Africa/Cairo",
"elevM": 23,
"elevFT": 75
}
}
]
}

View File

@ -1,169 +1,691 @@
<?xml version="1.0" encoding="UTF-8"?>
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on July 19, 2020</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT03874338</url>
</required_header>
<id_info>
<org_study_id>18-01323</org_study_id>
<secondary_id>1R01HL146206</secondary_id>
<nct_id>NCT03874338</nct_id>
</id_info>
<brief_title>CLEAR SYNERGY Neutrophil Substudy</brief_title>
<official_title>Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>NYU Langone Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Population Health Research Institute</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>NYU Langone Health</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 4, 2019</start_date>
<completion_date type="Anticipated">February 1, 2022</completion_date>
<primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>soluble L-selectin</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Change in soluble L-selectin between baseline and 3 mo after STEMI in the placebo vs. colchicine groups.</description>
</primary_outcome>
<secondary_outcome>
<measure>Other soluble markers of neutrophil activity</measure>
<time_frame>between baseline and 3 months</time_frame>
<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)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Markers of systemic inflammation</measure>
<time_frame>between baseline and 3 months</time_frame>
<description>Markers of systemic inflammation will be evaluated at baseline and 3 months after STEMI (high sensitive CRP, IL-1β)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neutrophil-driven responses that may further propagate injury</measure>
<time_frame>between baseline and 3 months</time_frame>
<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)</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">670</enrollment>
<condition>Neutrophils.Hypersegmented &#X7C; Bld-Ser-Plas</condition>
<condition>STEMI - ST Elevation Myocardial Infarction</condition>
<arm_group>
<arm_group_label>Colchicine</arm_group_label>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Colchicine Pill</intervention_name>
<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.</description>
<arm_group_label>Colchicine</arm_group_label>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>110 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Binita Shah, MD</last_name>
<role>Principal Investigator</role>
<affiliation>NYU School of Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Fatmira Curovic</last_name>
<phone>646-501-9648</phone>
<email>fatmira.curovic@nyumc.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Binita Shah, MD</last_name>
</overall_contact_backup>
<location>
<facility>
<name>NYU School of Medicine</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Fatmira Curovic</last_name>
<phone>646-501-9648</phone>
<email>fatmira.curovic@nyumc.org</email>
</contact>
<contact_backup>
<last_name>Binita Shah, MD</last_name>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2019</verification_date>
<study_first_submitted>March 12, 2019</study_first_submitted>
<study_first_submitted_qc>March 12, 2019</study_first_submitted_qc>
<study_first_posted type="Actual">March 14, 2019</study_first_posted>
<last_update_submitted>September 10, 2019</last_update_submitted>
<last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
<last_update_posted type="Actual">September 12, 2019</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>NYU Langone Health</investigator_affiliation>
<investigator_full_name>Binita Shah</investigator_full_name>
<investigator_title>Assistant Professor of Medicine</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myocardial Infarction</mesh_term>
<mesh_term>ST Elevation Myocardial Infarction</mesh_term>
<mesh_term>Infarction</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Colchicine</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
<success>true</success>
<response>
<loc>
<long>31.25</long>
<lat>30.063</lat>
</loc>
<profile>
<elevM>23</elevM>
<tz>Africa/Cairo</tz>
<elevFT>75</elevFT>
</profile>
<periods>
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<weather>Mostly Sunny</weather>
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<weatherPrimary>Mostly Sunny</weatherPrimary>
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<windSpeedMaxKPH>16</windSpeedMaxKPH>
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<feelslikeF>70</feelslikeF>
<validTime>2022-10-06T07:00:00+02:00</validTime>
<windSpeedMin80mMPH>10</windSpeedMin80mMPH>
<solradMaxWM2>778</solradMaxWM2>
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<weatherPrimaryCoded>::FW</weatherPrimaryCoded>
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<icon>fair.png</icon>
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<periods>
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<windDir>N</windDir>
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<windDirMin>N</windDirMin>
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<icon>pcloudy.png</icon>
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<sunset>1665329491</sunset>
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</periods>
<periods>
<dateTimeISO>2022-10-10T07:00:00+02:00</dateTimeISO>
<windDirMin80m>E</windDirMin80m>
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<windDirDEG>358</windDirDEG>
<windDir>N</windDir>
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<iceaccumMM>null</iceaccumMM>
<windSpeedMaxKTS>8</windSpeedMaxKTS>
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<snowIN>0</snowIN>
<weather>Partly Cloudy</weather>
<sunsetISO>2022-10-10T17:30:21+02:00</sunsetISO>
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<weatherPrimaryCoded>::SC</weatherPrimaryCoded>
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<icon>pcloudy.png</icon>
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<windDirMax>N</windDirMax>
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<pressureMB>1017</pressureMB>
<visibilityKM>24.135</visibilityKM>
<timestamp>1665378000</timestamp>
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<windDirMax80m>N</windDirMax80m>
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<pressureIN>30.03</pressureIN>
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<iceaccum>null</iceaccum>
<isDay>true</isDay>
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<sunset>1665415821</sunset>
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<windSpeedMPH>2</windSpeedMPH>
<windGustKPH>30</windGustKPH>
<windDirMaxDEG>10</windDirMaxDEG>
<tempC>null</tempC>
</periods>
<periods>
<dateTimeISO>2022-10-11T07:00:00+02:00</dateTimeISO>
<windDirMin80m>NNE</windDirMin80m>
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<windDirDEG>13</windDirDEG>
<windDir>NNE</windDir>
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<weather>Sunny</weather>
<sunsetISO>2022-10-11T17:29:13+02:00</sunsetISO>
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<windDir80m>NNE</windDir80m>
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<weatherPrimaryCoded>::CL</weatherPrimaryCoded>
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<windDirMin>NNE</windDirMin>
<maxCoverage/>
<icon>sunny.png</icon>
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<windSpeed80mKTS>10</windSpeed80mKTS>
<pop>0</pop>
<snowCM>0</snowCM>
<windDirMax>NNE</windDirMax>
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<maxTempC>31</maxTempC>
<pressureMB>1015</pressureMB>
<visibilityKM>24.135</visibilityKM>
<timestamp>1665464400</timestamp>
<maxTempF>87</maxTempF>
<tempF>null</tempF>
<minDewpointC>11</minDewpointC>
<solradMinWM2>0</solradMinWM2>
<windSpeedMinKTS>7</windSpeedMinKTS>
<windDirMax80mDEG>28</windDirMax80mDEG>
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<windSpeedMinKPH>14</windSpeedMinKPH>
<maxDewpointF>62</maxDewpointF>
<windSpeedMinMPH>8</windSpeedMinMPH>
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<uvi>null</uvi>
<windDirMax80m>NNE</windDirMax80m>
<maxDewpointC>17</maxDewpointC>
<pressureIN>29.98</pressureIN>
<avgFeelslikeF>79</avgFeelslikeF>
<iceaccum>null</iceaccum>
<isDay>true</isDay>
<minTempC>21</minTempC>
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<windSpeedKTS>8</windSpeedKTS>
<sunset>1665502153</sunset>
<solradWM2>5450</solradWM2>
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<windSpeedMPH>9</windSpeedMPH>
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<windDirMaxDEG>28</windDirMaxDEG>
<tempC>null</tempC>
</periods>
<periods>
<dateTimeISO>2022-10-12T07:00:00+02:00</dateTimeISO>
<windDirMin80m>NNE</windDirMin80m>
<windDirMin80mDEG>15</windDirMin80mDEG>
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<visibilityMI>15</visibilityMI>
<windSpeedMaxMPH>16</windSpeedMaxMPH>
<windDirDEG>12</windDirDEG>
<windDir>NNE</windDir>
<sunriseISO>2022-10-12T05:54:55+02:00</sunriseISO>
<iceaccumMM>null</iceaccumMM>
<windSpeedMaxKTS>14</windSpeedMaxKTS>
<iceaccumIN>null</iceaccumIN>
<minTempF>69</minTempF>
<snowIN>0</snowIN>
<weather>Mostly Sunny</weather>
<sunsetISO>2022-10-12T17:28:04+02:00</sunsetISO>
<maxFeelslikeC>31</maxFeelslikeC>
<humidity>68</humidity>
<windDir80m>NNE</windDir80m>
<maxFeelslikeF>88</maxFeelslikeF>
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<sky>27</sky>
<windGust80mMPH>21</windGust80mMPH>
<windSpeedMax80mMPH>21</windSpeedMax80mMPH>
<weatherPrimary>Mostly Sunny</weatherPrimary>
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<avgDewpointF>55</avgDewpointF>
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<feelslikeF>72</feelslikeF>
<validTime>2022-10-12T07:00:00+02:00</validTime>
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<solradMaxWM2>743</solradMaxWM2>
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<weatherPrimaryCoded>::FW</weatherPrimaryCoded>
<sunrise>1665546895</sunrise>
<avgTempF>79</avgTempF>
<windDirMin>NNE</windDirMin>
<maxCoverage/>
<icon>fair.png</icon>
<minFeelslikeC>22</minFeelslikeC>
<dewpointC>16</dewpointC>
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<windSpeed80mKTS>10</windSpeed80mKTS>
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<pressureIN>29.95</pressureIN>
<avgFeelslikeF>80</avgFeelslikeF>
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<windSpeedKTS>8</windSpeedKTS>
<sunset>1665588484</sunset>
<solradWM2>4740</solradWM2>
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<windGustMPH>17</windGustMPH>
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<windSpeedMPH>9</windSpeedMPH>
<windGustKPH>28</windGustKPH>
<windDirMaxDEG>96</windDirMaxDEG>
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</periods>
<interval>day</interval>
<place>
<country>eg</country>
<name>cairo</name>
<state>qh</state>
</place>
</response>
<error>null</error>