Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03745664
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2018-11-14
Brief Title:
Corticosteroids and Myocardial Injury in CAP COLOSSEUM TRIAL
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLOSSEUM
Brief Summary:
Community-acquired pneumonia CAP is often complicated by elevation of cardiac troponin a marker of myocardial injury that can be isolated or associated to myocardial infarction MI A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay
The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone 20 mg bid may reduce myocardial injury as assessed by serum high-sensitivity cardiac T Troponin and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP
The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone 20 mg bid may reduce myocardial injury as assessed by serum high-sensitivity cardiac T Troponin and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP
Detailed Description:
Background Community-acquired pneumonia CAP is often complicated by elevation of cardiac troponin a marker of myocardial injury that can be isolated or associated to myocardial infarction MI A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients
Study design Double-blind randomized placebo-controlled trial One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone 20 mg bid or placebo from hospital admission Serum hs-cTnT will be measured at admission and every day until up 3 days from admission ECG will be monitored every day until discharge After dismission all patients will be followed-up 2 years
Aims of the study Primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury as assessed by serum high-sensitivity cardiac T Troponin hs-cTnT in a cohort of patients hospitalized for CAP
Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization at 30 day from hospital admission and during 2 years follow-up The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation
Study design Double-blind randomized placebo-controlled trial One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone 20 mg bid or placebo from hospital admission Serum hs-cTnT will be measured at admission and every day until up 3 days from admission ECG will be monitored every day until discharge After dismission all patients will be followed-up 2 years
Aims of the study Primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury as assessed by serum high-sensitivity cardiac T Troponin hs-cTnT in a cohort of patients hospitalized for CAP
Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization at 30 day from hospital admission and during 2 years follow-up The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None