Cardiomyocyte Injury Following Acute Ischemic Stroke (CORONA-IS)

Charité University Medicine Berlin

Status: Active, not recruiting

Conditions: Cardiac Complication; Stroke, Ischemic

Study type: Observational

Funder types: Other

Identifiers

NCT03892226

EA4/123/18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

1, no myocardial injury

Description:

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

2, chronic myocardial injury

Description:

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

3, acute myocardial injury

Description:

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