Trial Outcomes & Findings for PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE (NCT NCT03609385)
NCT ID: NCT03609385
Last Updated: 2025-03-26
Results Overview
the diagnosis will be established by an independent endpoint committee
Recruitment status
COMPLETED
Target enrollment
254 participants
Primary outcome timeframe
within seven days of admission to hospital
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
Stroke Patients With Elevated Troponin
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
|
|---|---|
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Overall Study
STARTED
|
254
|
|
Overall Study
COMPLETED
|
247
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
Baseline characteristics by cohort
| Measure |
Stroke Patients With Elevated Troponin
n=247 Participants
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
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|---|---|
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Age, Continuous
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75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
240 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
247 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within seven days of admission to hospitalthe diagnosis will be established by an independent endpoint committee
Outcome measures
| Measure |
Stroke Patients With Elevated Troponin
n=247 Participants
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
|
|---|---|
|
Presence of Myocardial Infarction
myocardial infarction
|
126 Participants
|
|
Presence of Myocardial Infarction
no myocardial infarction
|
121 Participants
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SECONDARY outcome
Timeframe: at one week and at three and twelve months after the initial event, at 12 months reported.mortality will be recorded during the stay in hospital as well as after three and twelve months
Outcome measures
| Measure |
Stroke Patients With Elevated Troponin
n=247 Participants
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
|
|---|---|
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Mortality
number of patients dead after one year
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39 Participants
|
|
Mortality
number of patients alive after one year
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208 Participants
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SECONDARY outcome
Timeframe: at baseline, at one week and at three and twelve months after the initial event, 12 months reportedPopulation: patients with available mRS after one year
functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)
Outcome measures
| Measure |
Stroke Patients With Elevated Troponin
n=213 Participants
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
|
|---|---|
|
Functional Outcome
mRS 0
|
66 participants
|
|
Functional Outcome
mRS 1
|
35 participants
|
|
Functional Outcome
mRS 2
|
23 participants
|
|
Functional Outcome
mRS 3
|
25 participants
|
|
Functional Outcome
mRS 4
|
21 participants
|
|
Functional Outcome
mRS 5
|
4 participants
|
|
Functional Outcome
mRS 6
|
39 participants
|
SECONDARY outcome
Timeframe: at one week and at three and twelve months after the initial event, 12 months reportedPopulation: participants with available follow-up data on cardiovascular events
cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality
Outcome measures
| Measure |
Stroke Patients With Elevated Troponin
n=229 Participants
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
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|---|---|
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Cardiovascular Events
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60 Participants
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Adverse Events
Stroke Patients With Elevated Troponin
Serious events: 7 serious events
Other events: 0 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Stroke Patients With Elevated Troponin
n=247 participants at risk
Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
|
|---|---|
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Cardiac disorders
recurrent myocardial infarction
|
0.40%
1/247 • Number of events 1 • 1 year
Only severe adverse events of special interest (SAESI), i.e., MI, repeated coronary intervention, ischemic stroke or TIA, peripheral embolic artery occlusion, intracranial hemorrhage, major bleeding (type 3-5 according to BARC classification), and death were monitored for/assessed for. Other types of SAEs and Other (Not Including Serious) Adverse Events were not monitored/assessed, however, since the PRAISE study is observational and does not fall under the German Medicinal Products Act (AMG).
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|
Nervous system disorders
ischemic stroke or TIA due to coronary angiography
|
0.81%
2/247 • Number of events 2 • 1 year
Only severe adverse events of special interest (SAESI), i.e., MI, repeated coronary intervention, ischemic stroke or TIA, peripheral embolic artery occlusion, intracranial hemorrhage, major bleeding (type 3-5 according to BARC classification), and death were monitored for/assessed for. Other types of SAEs and Other (Not Including Serious) Adverse Events were not monitored/assessed, however, since the PRAISE study is observational and does not fall under the German Medicinal Products Act (AMG).
|
|
Vascular disorders
peripheral artery occlusion due to coronary angiography
|
0.40%
1/247 • Number of events 1 • 1 year
Only severe adverse events of special interest (SAESI), i.e., MI, repeated coronary intervention, ischemic stroke or TIA, peripheral embolic artery occlusion, intracranial hemorrhage, major bleeding (type 3-5 according to BARC classification), and death were monitored for/assessed for. Other types of SAEs and Other (Not Including Serious) Adverse Events were not monitored/assessed, however, since the PRAISE study is observational and does not fall under the German Medicinal Products Act (AMG).
|
|
Vascular disorders
major bleeding after coronary angiography
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0.81%
2/247 • Number of events 2 • 1 year
Only severe adverse events of special interest (SAESI), i.e., MI, repeated coronary intervention, ischemic stroke or TIA, peripheral embolic artery occlusion, intracranial hemorrhage, major bleeding (type 3-5 according to BARC classification), and death were monitored for/assessed for. Other types of SAEs and Other (Not Including Serious) Adverse Events were not monitored/assessed, however, since the PRAISE study is observational and does not fall under the German Medicinal Products Act (AMG).
|
|
Cardiac disorders
death due to coronary angiography
|
0.40%
1/247 • Number of events 1 • 1 year
Only severe adverse events of special interest (SAESI), i.e., MI, repeated coronary intervention, ischemic stroke or TIA, peripheral embolic artery occlusion, intracranial hemorrhage, major bleeding (type 3-5 according to BARC classification), and death were monitored for/assessed for. Other types of SAEs and Other (Not Including Serious) Adverse Events were not monitored/assessed, however, since the PRAISE study is observational and does not fall under the German Medicinal Products Act (AMG).
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christian Nolte
Charité-Universitätsmedizin Berlin
Phone: +4930450560676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place