Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction
NCT05462730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 530
Last updated 2026-03-27
Summary
The overall primary objective of the PULSE-MI trial is to test the hypothesis that administration of single-dose glucocorticoid pulse therapy in the pre-hospital setting reduces final infarct size in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI)
Conditions
- ST Elevation Myocardial Infarction
- Inflammatory Response
- Myocardial Reperfusion Injury
- Myocardial Injury
Interventions
- DRUG
-
Methylprednisolone
A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
- DRUG
-
Isotonic saline
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Sponsors & Collaborators
-
Thomas Engstrom
lead OTHER
Principal Investigators
-
Jacob T Lønborg, MD, DMSc · Rigshospitalet, Denmark
-
Jasmine M Madsen, MD · Rigshospitalet, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-14
- Primary Completion
- 2024-01-30
- Completion
- 2024-10-17
Countries
- Denmark
Study Locations
More Related Trials
-
Intramyocardial Haemorrhage in Patients With Primary STEMI
NCT03677466 ·Status: COMPLETED ·Phase: NA
-
MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction Patients
NCT00078013 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of TG100-115 for Heart Attack Treated With Angioplasty
NCT00103350 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial
NCT01969890 ·Status: TERMINATED ·Phase: PHASE3
-
Postconditioning in ST-elevation Myocardial Infarction
NCT00922675 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
NCT05497011 ·Status: WITHDRAWN ·Phase: NA
-
Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris
NCT04496648 ·Status: UNKNOWN ·Phase: NA
-
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
NCT04566289 ·Status: WITHDRAWN
-
A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.
NCT04958421 ·Status: TERMINATED ·Phase: NA
-
A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks
NCT00604695 ·Status: COMPLETED ·Phase: PHASE2
-
Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction
NCT02164695 ·Status: COMPLETED ·Phase: NA
-
MYTHS - MYocarditis THerapy With Steroids
NCT05150704 ·Status: RECRUITING ·Phase: PHASE3
-
The Thrombus Aspiration During PCI After Thrombolysis in STEMI
NCT06654453 ·Status: RECRUITING ·Phase: NA
-
Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
NCT03435133 ·Status: COMPLETED ·Phase: NA
-
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
NCT02070471 ·Status: COMPLETED ·Phase: PHASE2
-
Predictors of Failed Thrombolysis in Acute Myocardial Infarction
NCT05347732 ·Status: RECRUITING
-
IK-1001 (Sodium Sulfide (Na2S) for Injection) in Subjects With Acute ST-Segment Elevation Myocardial Infarction
NCT01007461 ·Status: WITHDRAWN ·Phase: PHASE2
-
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
NCT00192868 ·Status: UNKNOWN ·Phase: NA
-
Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
NCT02894138 ·Status: UNKNOWN ·Phase: PHASE3
-
Adjunctive, Low-dose tPA in Primary PCI for STEMI
NCT03335839 ·Status: COMPLETED ·Phase: PHASE3
-
Thrombectomy in Acute Myocardial Infarction
NCT00675480 ·Status: COMPLETED ·Phase: PHASE3
-
Remote Ischemic Preconditioning in Primary PCI
NCT00435266 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
NCT03947619 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Ischemic Postconditioning in STEMI Patients Treated With Primary PCI
NCT03787745 ·Status: RECRUITING ·Phase: NA
-
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
NCT00507156 ·Status: COMPLETED ·Phase: PHASE4