Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL) (COLOSSEUM)
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL
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 b.i.d) 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.
연구 개요
상태
정황
상세 설명
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 b.i.d) 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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Francesco Violi, MD
- 전화번호: +39 064461933
- 이메일: francesco.violi@uniroma1.it
연구 연락처 백업
- 이름: Roberto Cangemi, MD, PhD
- 전화번호: +39 3358093936
- 이메일: roberto.cangemi@uniroma1.it
연구 장소
-
-
-
Rome, 이탈리아, 00161
- 모병
- Sapienza University of Rome
-
연락하다:
- Lorenzo Loffredo, MD
- 전화번호: +39-06-49970103
- 이메일: lorenzo.loffredo@uniroma1.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Hospitalization for community-acquired pneumonia
Exclusion Criteria:
- Use of corticosteroids in the previous 30 days
- Health Care-Associated Pneumonia
- Reported severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
- Preexisting medical condition with a life expectancy of less than 3 months
- Uncontrolled diabetes mellitus
- Gastritis with or without major gastrointestinal bleeding within 3 months
- Any condition requiring acute treatment with glucocorticoids
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Treatment group
Methylprednisolone Sodium Succinate (20mg/ml) will be given at the dose of 40 mg/day (20 mg x 2/day). The treatment will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days). |
During hospitalization, 40 mg of methylprednisolone (20 mg/ml) will be given intravenously twice a day (20 mg every 12 hours).
|
|
위약 비교기: Placebo group
Saline Solution for Injection will be given ath the dose of 2 ml/day.
The treatment placebo will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days).
|
During hospitalization, 2 ml of Saline Solution for Injection will be given intravenously twice a day (2 ml every 12 hours).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
High sensitivity cardiac T troponin (myocardial injury biomarker)
기간: 7 days
|
Primary endpoint of the study will be a significant reduction of hs-cTnT increase.
Hs-cTnT will be measured .
Hs-cTnT levels will be measured by the Elecsys 2010 (Roche Diagnostics, Indianapolis, IN) in a dedicated core laboratory.
|
7 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum TxB2 (biomarker of platelet activation)
기간: 7 days
|
Serum Thromboxane (Tx) B2 will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
|
7 days
|
|
sP-selectin (biomarker of platelet activation).
기간: 7 days
|
Plasma sP-selectin will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
|
7 days
|
|
sCD40L (biomarker of platelet activation).
기간: 7 days
|
Plasma sCD40L will be measured on blood sample obtained at admission, after 72 hours and at hospital discharge (within 7 days).
|
7 days
|
|
High-sensitivity C-Reactive Protein
기간: 7 days
|
Serum high-sensitivity C-Reactive Protein will be measured in blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
|
7 days
|
|
Serum sNOX2-dp (biomarker of oxidative stress)
기간: 7 days
|
Serum sNOX2-dp will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
Blood levels of soluble NOX2-derived peptide (sNOX2-dp), a marker of NADPH oxidase activation, will be detected by ELISA as previously described (Pignatelli P et al Arterioscler Thromb Vasc Biol 2010;30:360-7).
|
7 days
|
|
Serum F2-isoprostanes (biomarker of oxidative stress)
기간: 7 days
|
Serum F2-isoprostane (8-iso-PGF2α -III) will be measured by the enzyme immunoassay method in blood samples obtained at admission, after 72 horus and at hospital discharge (within 7 days).
|
7 days
|
|
Urinary F2-isoprostanes (biomarker of oxidative stress)
기간: 7 days
|
F2-isoprostanes will be measured in urine samples collected at admission, after 72 horus and at hospital discharge (within 7 days).
|
7 days
|
|
Cardiovascular events during hospitalization.
기간: 7 days
|
This composite outcome will consist in any of the following events during hospitalization: acute myocardial infarction, new or worsening heart failure, new onset atrial fibrillation, stroke, cardiovascular death.
|
7 days
|
|
Major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
기간: 30 days
|
This composite outcome will consist in any of the following events during a 30-days follow-up: cardiovascular death, myocardial infarction and stroke.
|
30 days
|
|
Major adverse cardiac and cerebrovascular events (MACCE) during a a long-term follow-up.
기간: 2 years
|
This composite outcome will consist in any of the following events during a 2-years f follow-up: cardiovascular death, myocardial infarction and stroke.
|
2 years
|
|
Short-term mortality
기간: 30 days
|
Death for any cause during a 30-days follow-up
|
30 days
|
|
Long-term mortality
기간: 2 years
|
Death for any cause during a2 years follow-up
|
2 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Francesco Violi, MD, University of Roma La Sapienza
- 연구 책임자: Roberto Cangemi, University of Roma La Sapienza
간행물 및 유용한 링크
일반 간행물
- Cangemi R, Casciaro M, Rossi E, Calvieri C, Bucci T, Calabrese CM, Taliani G, Falcone M, Palange P, Bertazzoni G, Farcomeni A, Grieco S, Pignatelli P, Violi F; SIXTUS Study Group; SIXTUS Study Group. Platelet activation is associated with myocardial infarction in patients with pneumonia. J Am Coll Cardiol. 2014 Nov 4;64(18):1917-25. doi: 10.1016/j.jacc.2014.07.985. Epub 2014 Oct 27.
- Cangemi R, Falcone M, Taliani G, Calvieri C, Tiseo G, Romiti GF, Bertazzoni G, Farcomeni A, Violi F; SIXTUS Study Group. Corticosteroid Use and Incident Myocardial Infarction in Adults Hospitalized for Community-acquired Pneumonia. Ann Am Thorac Soc. 2019 Jan;16(1):91-98. doi: 10.1513/AnnalsATS.201806-419OC.
- Cangemi R, Carnevale R, Nocella C, Calvieri C, Cammisotto V, Novo M, Castellani V, D'Amico A, Zerbinati C, Stefanini L, Violi F; SIXTUS Study Group. Glucocorticoids impair platelet thromboxane biosynthesis in community-acquired pneumonia. Pharmacol Res. 2018 May;131:66-74. doi: 10.1016/j.phrs.2018.03.014. Epub 2018 Mar 22. Erratum In: Pharmacol Res. 2018 Sep;135:268.
- Liverani E, Banerjee S, Roberts W, Naseem KM, Perretti M. Prednisolone exerts exquisite inhibitory properties on platelet functions. Biochem Pharmacol. 2012 May 15;83(10):1364-73. doi: 10.1016/j.bcp.2012.02.006. Epub 2012 Feb 16.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- COLOSSEUM trial - Rif 5133
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Methylprednisolone Sodium Succinate에 대한 임상 시험
-
University Children's Hospital Basel완전한SARS-CoV-2(PIMS-TS)와 일시적으로 관련된 소아 염증성 다중 시스템 증후군스위스
-
National Institute of Allergy and Infectious Diseases...완전한
-
Paradigm Biopharmaceuticals USA (INC)모집하지 않고 적극적으로
-
Shandong New Time Pharmaceutical Co., LTD아직 모집하지 않음
-
SB Istanbul Education and Research HospitalBezmialem Vakif University모병
-
Cytonet GmbH & Co. KGCRS Clinical Research Services Mannheim GmbH완전한
-
Pfizer완전한
-
Astellas Pharma Inc완전한