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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
| German Center for Neurodegenerative Diseases (DZNE) | OTHER |
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The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.
Elevation of cardiac troponin can be found in about 30% of patients with acute ischemic stroke (depending on the assay used). Elevated troponin indicates increased mortality in stroke patients. There is currently little evidence regarding the ideal care of these patients. The investigators know from previous studies that approximately 25% of acute stroke patients with elevated levels of cardiac troponin have culprit lesions on coronary angiogram.
The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients. To achieve this, clinical symptoms, troponin levels as well as findings on EKG, echocardiography and coronary angiography will be systematically evaluated. The PRAISE study is a multicenter study with more than 20 sites in Germany. Joint funding will be provided by DZHK (German center of cardiovascular research) und DZNE (German center of neurodegenerative diseases). Acute ischaemic stroke patients with elevated troponin are eligible for participation in the study. The primary endpoint is the diagnosis of acute coronary syndrome as established by an independent endpoint committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angiography | Diagnostic Test | In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Myocardial Infarction | the diagnosis will be established by an independent endpoint committee | within seven days of admission to hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | mortality will be recorded during the stay in hospital as well as after three and twelve months | at one week and at three and twelve months after the initial event, at 12 months reported. |
| Functional Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive patients with acute ischemic stroke admitted to the participating sites will be systematically screened for eligibility
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Endres, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Ulf Landmesser, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Christian Nolte, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhön-Klinikum Campus Bad Neustadt | Bad Neustadt an der Saale | Germany | ||||
| Charité-Campus Mitte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32854663 | Background | Nolte CH, von Rennenberg R, Litmeier S, Scheitz JF, Leistner DM, Blankenberg S, Dichgans M, Katus H, Petzold GC, Pieske B, Regitz-Zagrosek V, Wegscheider K, Zeiher AM, Landmesser U, Endres M. PRediction of acute coronary syndrome in acute ischemic StrokE (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints. BMC Neurol. 2020 Aug 27;20(1):318. doi: 10.1186/s12883-020-01903-0. | |
| 38829625 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2018 | Oct 24, 2024 |
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functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)
| at baseline, at one week and at three and twelve months after the initial event, 12 months reported |
| Cardiovascular Events | cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality | at one week and at three and twelve months after the initial event, 12 months reported |
| Berlin |
| 10117 |
| Germany |
| Charité-Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Charité-Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Jüdisches Krankenhaus | Berlin | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Allgemeines Krankenhaus Celle | Celle | Germany |
| Universitätsklinikum Dresden | Dresden | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Klinikum Friedrichshafen | Friedrichshafen | Germany |
| Klinikum Fulda | Fulda | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Universitätsklinikum Greifswald | Greifswald | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | Germany |
| Universitätsklinikum Mannheim | Mannheim | Germany |
| Universitätsklinikum der Ludwig-Maximilians-Universität München | Munich | Germany |
| Technische Universität München (TUM) | München | Germany |
| Klinikum Nürnberg Süd | Nuremberg | Germany |
| Klinikum Osnabrück | Osnabrück | Germany |
| Universitätsmedizin Rostock | Rostock | Germany |
| Universitätsklinikum Tübingen | Tübingen | Germany |
| Universitätsklinikum Ulm | Ulm | Germany |
| Result |
| Nolte CH, von Rennenberg R, Litmeier S, Leistner DM, Szabo K, Baumann S, Mengel A, Michalski D, Siepmann T, Blankenberg S, Petzold GC, Dichgans M, Katus H, Pieske B, Regitz-Zagrosek V, Braemswig TB, Rangus I, Pepic A, Vettorazzi E, Zeiher AM, Scheitz JF, Wegscheider K, Landmesser U, Endres M. Type 1 Myocardial Infarction in Patients With Acute Ischemic Stroke. JAMA Neurol. 2024 Jul 1;81(7):703-711. doi: 10.1001/jamaneurol.2024.1552. |
| 41189028 | Derived | von Rennenberg R, Litmeier S, Szabo K, Mengel A, Petersen M, Wunderlich S, Michalski D, Thomalla G, Kallmunzer B, Petzold G, Dichgans M, Siepmann T, Royl G, Ringleb PA, Nolte CH, Endres M. Cognitive performance in patients with ischemic stroke and additional myocardial injury - results from the multicenter prospective observational PRAISE study. Neurol Res Pract. 2025 Nov 4;7(1):84. doi: 10.1186/s42466-025-00446-4. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of Myocardial Infarction | the diagnosis will be established by an independent endpoint committee | Posted | Count of Participants | Participants | within seven days of admission to hospital |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Mortality | mortality will be recorded during the stay in hospital as well as after three and twelve months | Posted | Count of Participants | Participants | at one week and at three and twelve months after the initial event, at 12 months reported. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Functional Outcome | functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome) | patients with available mRS after one year | Posted | Number | participants | at baseline, at one week and at three and twelve months after the initial event, 12 months reported |
|
| |||||||||||||||||||||||||||||
| Secondary | Cardiovascular Events | cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality | participants with available follow-up data on cardiovascular events | Posted | Count of Participants | Participants | at one week and at three and twelve months after the initial event, 12 months reported |
|
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 39 | 247 | 7 | 247 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| recurrent myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| ischemic stroke or TIA due to coronary angiography | Nervous system disorders | Systematic Assessment |
| ||
| peripheral artery occlusion due to coronary angiography | Vascular disorders | Systematic Assessment |
| ||
| major bleeding after coronary angiography | Vascular disorders | Systematic Assessment |
| ||
| death due to coronary angiography | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christian Nolte | Charité-Universitätsmedizin Berlin | +4930450560676 | christian.nolte@charite.de |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2022 | Jul 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D054058 | Acute Coronary Syndrome |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D017023 | Coronary Angiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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