Trial Outcomes & Findings for Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction (NCT NCT05462730)
NCT ID: NCT05462730
Last Updated: 2026-03-27
Results Overview
% of the left ventricle mass measured by late-gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR)
COMPLETED
PHASE2
530 participants
3 months following STEMI
2026-03-27
Participant Flow
Patients with STEMI were screened for eligibility randomized in the prehospital setting prior to acute coronary angiogram (CAG) at Rigshospitalet, Denmark. Postrandomization exclusion occurred in patients who were randomized but did not fulfill criteria for inclusion or had other subtypes of myocardial infarction than type 1 after the acute CAG. Randomization of patients continued until 378 patients had completed the follow-up cardiac magnetic resonance scan according to the power calculation.
Participant milestones
| Measure |
Methylprednisolone
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
Isotonic Saline
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
|---|---|---|
|
Overall Study
STARTED
|
262
|
268
|
|
Overall Study
COMPLETED
|
198
|
203
|
|
Overall Study
NOT COMPLETED
|
64
|
65
|
Reasons for withdrawal
| Measure |
Methylprednisolone
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
Isotonic Saline
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
59
|
61
|
|
Overall Study
Primary outcome not evaluable
|
5
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methylprednisolone
n=262 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
Isotonic Saline
n=268 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Total
n=530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=262 Participants
|
65 years
n=268 Participants
|
65 years
n=530 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=262 Participants
|
59 Participants
n=268 Participants
|
112 Participants
n=530 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=262 Participants
|
209 Participants
n=268 Participants
|
418 Participants
n=530 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Culprit artery
LAD
|
115 Participants
n=262 Participants
|
115 Participants
n=268 Participants
|
230 Participants
n=530 Participants
|
|
Culprit artery
LCX
|
44 Participants
n=262 Participants
|
49 Participants
n=268 Participants
|
93 Participants
n=530 Participants
|
|
Culprit artery
LM
|
6 Participants
n=262 Participants
|
2 Participants
n=268 Participants
|
8 Participants
n=530 Participants
|
|
Culprit artery
RCA
|
97 Participants
n=262 Participants
|
102 Participants
n=268 Participants
|
199 Participants
n=530 Participants
|
|
TIMI flow pre-PCI 0-1 on angio at arrival
|
143 Participants
n=262 Participants
|
138 Participants
n=268 Participants
|
281 Participants
n=530 Participants
|
PRIMARY outcome
Timeframe: 3 months following STEMIPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
% of the left ventricle mass measured by late-gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR)
Outcome measures
| Measure |
Isotonic Saline
n=203 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=198 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
Final Infarct Size
|
6 % of LV
Interval 2.0 to 13.0
|
5 % of LV
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: During admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Microvascular obstruction (MVO) within the LGE identified on CMR
Outcome measures
| Measure |
Isotonic Saline
n=170 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=162 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: The Extent of MVO
|
0.6 % of LV
Interval 0.0 to 2.1
|
0.3 % of LV
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: During admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Number of Participants with T2\*-CMR Identified Hemorrhage
Outcome measures
| Measure |
Isotonic Saline
n=165 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=160 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: The Extent of Haemorrhage
|
63 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: During admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
umber of Participants with Presence of MVO (Hypodense areas within the LGE areas)
Outcome measures
| Measure |
Isotonic Saline
n=170 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=162 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: MVO
|
115 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: During admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Visible edema (hypodense areas) on 3D CINE SAX images
Outcome measures
| Measure |
Isotonic Saline
n=171 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=162 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: Area at Risk
|
30 % of LV
Standard Deviation 12
|
28 % of LV
Standard Deviation 13
|
SECONDARY outcome
Timeframe: During admission and 3 months following STEMIPopulation: Acute MSI. All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Myocardial salvage index (MSI)=infarct size/area-at-risk\*100. MSI will be measured and calculated at the acute CMR and follow-up CMR
Outcome measures
| Measure |
Isotonic Saline
n=154 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=144 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: MSI
|
50 % of area at risk
Interval 35.0 to 68.0
|
55 % of area at risk
Interval 38.0 to 72.0
|
SECONDARY outcome
Timeframe: During admission and 3 months following STEMIPopulation: Acute LVEF. All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Evaluated on 3D CINE SAX images at the acute and follow-up CMR.
Outcome measures
| Measure |
Isotonic Saline
n=173 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=163 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
CMR Efficacy: LVEF
|
30 % of LV
Standard Deviation 12
|
28 % of LV
Standard Deviation 13
|
SECONDARY outcome
Timeframe: During admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Peak Troponin-T during admission
Outcome measures
| Measure |
Isotonic Saline
n=267 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=262 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
Peak Troponin-T
|
2840 ng/L
Interval 1014.0 to 6400.0
|
2205 ng/L
Interval 876.0 to 5088.0
|
SECONDARY outcome
Timeframe: 3 months following STEMIPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
All-cause mortality at 3 months
Outcome measures
| Measure |
Isotonic Saline
n=268 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=262 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
All-cause Mortality
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 7 days following admissionPopulation: All analyseswere performedin the modified intentionto- treat population, which did not include postrandomization exclusions. The modified intention-to-treat populations was prespecified and unchanged during the trial.
Safety outcome on adverse events
Outcome measures
| Measure |
Isotonic Saline
n=268 Participants
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
Methylprednisolone
n=262 Participants
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
|---|---|---|
|
Safety: Incidence of Adverse Events
|
14 Participants
|
11 Participants
|
Adverse Events
Methylprednisolone
Isotonic Saline
Serious adverse events
| Measure |
Methylprednisolone
n=382 participants at risk
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
Isotonic Saline
n=360 participants at risk
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
|---|---|---|
|
General disorders
Resulting in incapacity
|
0.26%
1/382 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
0.00%
0/360 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
|
General disorders
Prolongation of or new hospitalization
|
15.2%
58/382 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
13.6%
49/360 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
|
General disorders
Life threatening
|
7.9%
30/382 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
7.2%
26/360 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
Other adverse events
| Measure |
Methylprednisolone
n=382 participants at risk
A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.
Methylprednisolone: A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
|
Isotonic Saline
n=360 participants at risk
A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
Isotonic saline: A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
|
|---|---|---|
|
Infections and infestations
Infection
|
4.2%
16/382 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
3.9%
14/360 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
|
Skin and subcutaneous tissue disorders
Skin complication
|
0.79%
3/382 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
0.56%
2/360 • AE were recorded for 7 days. SAE were recorded for 3 months. All cause mortality was assessed after 3 months
The definitions does not differ
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place