PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

Acute Coronary Syndrome Clinical Trial

— PRAISE  

Official title:

PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609385
• Other study ID #: EA1/057/18
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: September 26, 2022

Study information

• Verified date: January 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 26, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic
• Syndrome

Intervention

Diagnostic Test:
• Coronary angiography
In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.

Locations

Country	Name	City	State
Germany	Rhön-Klinikum Campus Bad Neustadt	Bad Neustadt An Der Saale
Germany	Charité-Campus Benjamin Franklin	Berlin
Germany	Charité-Campus Mitte	Berlin
Germany	Charité-Campus Virchow Klinikum	Berlin
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	Technische Universität München (TUM)	München
Germany	Universitätsklinikum der Ludwig-Maximilians-Universität München	Munich
Germany	Klinikum Nürnberg Süd	Nürnberg
Germany	Klinikum Osnabrück	Osnabrück
Germany	Universitätsmedizin Rostock	Rostock
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of acute coronary syndrome	the diagnosis will be established by an independent endpoint committee	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	at one week and at three and twelve months after the initial event
Secondary	functional outcome	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
Secondary	cardiovascular events	cardiovascular events include new stroke, transient ischemic attack and myocardial infarction	at one week and at three and twelve months after the initial event