PRAISE: PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03609385
• Collaborator: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other), German Center for Neurodegenerative Diseases (DZNE) (Other)
• Enrollment: 251
• Locations: 28
• Anticipated Duration (Months): 51
• Patients Per Site: 9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic; Acute Coronary Syndrome	Diagnostic Test: Coronary angiography

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 251 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Dec 20, 2021
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: Coronary angiography; In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.

Outcome Measures

Primary Outcome Measures

1. presence of acute coronary syndrome [within seven days of admission to hospital]

   the diagnosis will be established by an independent endpoint committee

Secondary Outcome Measures

1. mortality [at one week and at three and twelve months after the initial event]

   mortality will be recorded during the stay in hospital as well as after three and twelve months

2. functional outcome [at baseline, at one week and at three and twelve months after the initial event]

   functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)

3. cardiovascular events [at one week and at three and twelve months after the initial event]

   cardiovascular events include new stroke, transient ischemic attack and myocardial infarction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of ischemic stroke based on clinical and imaging information (CT or MRI)

• diagnosis of transient ischemic attack if the initial focal neurological deficit has been examined by a neurologist and if the ABCD2-score is ≥ 4

• Elevation of high-sensitive cardiac troponins according to the rule-in/rule-out algorithm of the 2015 ESC guidelines for NSTE-ACS, i.e. highly abnormal troponin at 0 hours (> 52ng/l if hs-cTnT, Elecsys-Assay, or > 52ng/l, if hs-cTnI; Architect-Assay, or > 107 ng/l, if hs-cTnI. Dimension Vista Assay) or dynamic change > 20% of the initial value at re-test after 3 hours with at least one value above the 99th percentile of a healthy reference population

• ability to give informed consent

• onset of symptoms < 72 hours prior to hospital admission

Exclusion Criteria:

• renal insufficiency (GFR < 30 ml/min/m²)

• contraindications for coronary angiography (e.g. manifest hyperthyroidism, allergy to contrast agent)

• lesion size > 100 ml (either on Diffusion Weighted Imaging on cMRI or on CT if CT is performed > 24 hours after onset) or ASPECTS score < 7 (on CT if CT is performed < 24 hours after onset)

• Premorbid degree of dependence (mRS > 3)

• pregnancy or breast-feeding

• limited life expectancy < 1 year

• consent to participate in the study given > 72 hours after hospital admission

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rhön-Klinikum Campus Bad Neustadt	Bad Neustadt An Der Saale		Germany
2	Charité-Campus Mitte	Berlin		Germany	10117
3	Charité-Campus Benjamin Franklin	Berlin		Germany	12203
4	Charité-Campus Virchow Klinikum	Berlin		Germany	13353
5	Jüdisches Krankenhaus	Berlin		Germany
6	Universitätsklinikum Bonn	Bonn		Germany
7	Allgemeines Krankenhaus Celle	Celle		Germany
8	Universitätsklinikum Dresden	Dresden		Germany
9	Universitätsklinikum Erlangen	Erlangen		Germany
10	Universitätsklinikum Frankfurt	Frankfurt		Germany
11	Klinikum Friedrichshafen	Friedrichshafen		Germany
12	Klinikum Fulda	Fulda		Germany
13	Universitätsklinikum Greifswald	Greifswald		Germany
14	Universitätsmedizin Göttingen	Göttingen		Germany
15	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany
16	Universitätsklinikum Heidelberg	Heidelberg		Germany
17	Universitätsklinikum Jena	Jena		Germany
18	Universitätsklinikum Leipzig	Leipzig		Germany
19	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck		Germany
20	Universitätsklinikum Magdeburg	Magdeburg		Germany
21	Universitätsklinikum Mannheim	Mannheim		Germany
22	Universitätsklinikum der Ludwig-Maximilians-Universität München	Munich		Germany
23	Technische Universität München (TUM)	München		Germany
24	Klinikum Nürnberg Süd	Nürnberg		Germany
25	Klinikum Osnabrück	Osnabrück		Germany
26	Universitätsmedizin Rostock	Rostock		Germany
27	Universitätsklinikum Tübingen	Tübingen		Germany
28	Universitätsklinikum Ulm	Ulm		Germany

Sponsors and Collaborators

• Charite University, Berlin, Germany
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• German Center for Neurodegenerative Diseases (DZNE)

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthias Endres, Prof Dr med. Matthias Endres, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03609385
• Other Study ID Numbers: EA1/057/18
• First Posted: Aug 1, 2018
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matthias Endres, Prof Dr med. Matthias Endres, Charite University, Berlin, Germany: stroke; troponin; acute coronary syndrome; culprit lesion
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Acute Coronary Syndrome; Syndrome; Ischemia

Study Results

No Results Posted as of Mar 10, 2022