Cardiomyocyte Injury Following Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-12-31

Brief Summary

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The primary goal of the CORONA-IS study is to characterize stroke-associated acute myocardial injury (elevated hs-cardiac troponin) using different diagnostic examinations in order get a better understanding of it's underlying pathomechanisms.

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Detailed Description

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Myocardial injury (i.e. elevated cardiac troponin levels) is a frequent cardiac complication during the first few days after an ischemic stroke and is associated with a poor functional outcome. Myocardial injury represents one essential part of a broad spectrum of cardiac complications ranging to severe arrhythmia or heart failure. There is evidence that, in the majority of patients, the underlying mechanism of stroke-associated myocardial injury is not coronary-mediated myocardial ischemia but rather stroke-induced functional and structural interference in the central autonomic network. The investigators hypothesize that this causes a dysregulation of normal neuronal cardiac control leading to myocardial edema and stunning ('Stroke-Heart-Syndrome') CORONA-IS is a prospective, observational, single-centered cohort study that will recruit 300 patients with acute ischemic stroke. According to serial high sensitivity cTn levels during the first 24h after admission, patients will be assigned to three groups (no myocardial injury, chronic myocardial injury, acute myocardial injury). Study procedures include cardiovascular MRI and transthoracic echocardiography to visualize (transient) cardiac dysfunction and provide detailed tissue characterization, 20-minute Holter-monitoring with an analysis of specific autonomic markers, and a systematic bio-banking to study further mechanisms such as altered microRNA signatures. A follow-up for cardiovascular events will be conducted one year after enrolment to study long-term effects of stoke-associated myocardial injury.

The aim of the CORONA-IS study is to develop a better understanding of the characteristics and the pathophysiology of stroke-induced acute myocardial injury ('Stroke-Heart-Syndrome') in order to identify patients at risk and improve diagnostic and therapeutic procedures.

Conditions

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Stroke, Ischemic Cardiac Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1, no myocardial injury

normal troponin level (hs-troponin T ≤ 99. percentile, i.e. 14ng/ml)

No interventions assigned to this group

2, chronic myocardial injury

elevated, but stable troponin level; (hs-troponin T\> 99. percentile and rise/fall ≤ 20% in the control)

No interventions assigned to this group

3, acute myocardial injury

dynamic troponin elevation; (hs-troponin T\> 99. percentile and rise/fall \>20% in the control)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age over 18
* diagnosis of acute ischemic stroke and hospital admission within 48h after onset of the symptoms
* diagnosis based on visible DWI-lesion in MRI
* written informed consent by participant
* repeated measurement of high sensitive Troponin T within 24h of admission (hs-troponin T, Roche Elecsys®, 99. percentile, upper reference limit=14ng/l)

Exclusion Criteria

* Pregnancy and / or breast-feeding.
* Impaired renal function (eGFR \< 30 ml/min/1,73 m\^2)
* Contraindications to undergo MRI (i.e., mechanic heart valve, cardiac pacemaker, etc.)
* Persistent or permanent atrial fibrillation
* ST- elevation myocardial infarction
* History of coronary artery bypass surgery or percutaneous trans-luminal coronary angioplasty (PTCA) ≤ four weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No