Cardiomyocyte Injury Following Acute Ischemic Stroke (CORONA-IS)

February 19, 2024 updated by: Dr. med. Jan Friedrich Scheitz, Charite University, Berlin, Germany
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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charitè-Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

consecutive patients with acute ischemic stroke admitted to the hospital's stroke unit will be systematically screened for eligibility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1, no myocardial injury
normal troponin level (hs-troponin T ≤ 99. percentile, i.e. 14ng/ml)
2, chronic myocardial injury
elevated, but stable troponin level; (hs-troponin T> 99. percentile and rise/fall ≤ 20% in the control)
3, acute myocardial injury
dynamic troponin elevation; (hs-troponin T> 99. percentile and rise/fall >20% in the control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)
Time Frame: within five days of admission to hospital
diagnosed in cardiovascular MRI (CMR), conducted at the fourth/fifth day after onset of the ischemic stroke
within five days of admission to hospital
Rate of myocardial fibrosis with late Gadolinium enhancement (LGE) and acute edema in CMR
Time Frame: within five days of admission to hospital
Rate of myocardial fibrosis with LGE and acute edema in CMR, suggesting a recent myocardial infarction (<1 month). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
within five days of admission to hospital
Rate of signs of left ventricular dysfunction in the CMR
Time Frame: within five days of admission to hospital
Rate of signs of left ventricular dysfunction in the cardiac MRI (i.e. reduced ejection fraction, end diastolic left ventricular volume, longitudinal strain rate). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
within five days of admission to hospital
Rate of acute disturbance of microcirculation
Time Frame: within five days of admission to hospital
Rate of acute disturbance of microcirculation (measurement on the basis of oxygen extraction in cardiac MRI). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
within five days of admission to hospital
Rate of impaired left ventricular function and transient impaired left ventricular function in transthoracic echocardiography
Time Frame: within seven days of admission to hospital
Rate of impaired left ventricular function (ejection fraction <50%, reduced global longitudinal strain etc.) in the transthoracic echocardiography as well as higher rate of transient left ventricular dysfunction detected in repeated transthoracic echocardiography (TTE). The TTE will be conducted at the first day after enrolment as well as at the day before discharge or five days after the first TTE respectively.
within seven days of admission to hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC)
Time Frame: within seven days of admission to hospital
Rate of Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC) in the 20 minutes Holter ECG as sign of enhanced sympathetic activity (PRD> 5.75 deg^2, DC ≤2.5 ms).
within seven days of admission to hospital
Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke
Time Frame: within seven days of admission to hospital
Analysis of circulating microRNA pattern via next generation Sequencing in patient's blood samples.
within seven days of admission to hospital
Mortality
Time Frame: at one week and twelve months after the initial event
mortality (rate of deaths) will be recorded during the stay in hospital as well as after twelve months
at one week and twelve months after the initial event
Functional outcome
Time Frame: at baseline, at seven days after baseline (or at day of discharge from hospital if <7d, respectively) and at twelve months after the initial event
functional outcome will be evaluated using the 'modified Rankin scale' (range from 0 = no symptoms to 6 = death; favorable outcome defined as 0 or 1 in the modified Rankin scale)
at baseline, at seven days after baseline (or at day of discharge from hospital if <7d, respectively) and at twelve months after the initial event
Rate of cardiovascular events
Time Frame: at one week and at twelve months after the initial event
cardiovascular events include new stroke, transient ischemic attack and myocardial infarction
at one week and at twelve months after the initial event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Jan Scheitz, PD Dr. med., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/123/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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