Cardiomyocyte Injury Following Acute Ischemic Stroke

NCT03892226 | Active Not Recruiting

• 1 other identifier: EA4/123/18
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic; Cardiac Complication

Keywords

stroke; stroke-heart syndrome; troponin; myocardial stunning; acute coronary syndrome; periodic repolarization dynamics; cardiac complications

Outcome Measures

Primary Outcomes (5)

• Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)

  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

  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

  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

  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

  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 Outcomes (5)

• Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC)

  within seven days of admission to hospital

• Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke

  within seven days of admission to hospital

• Mortality

  at one week and twelve months after the initial event

• Functional outcome

  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

  at one week and at twelve months after the initial event

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Related Publications (6)

• Scheitz JF, Nolte CH, Doehner W, Hachinski V, Endres M. Stroke-heart syndrome: clinical presentation and underlying mechanisms. Lancet Neurol. 2018 Dec;17(12):1109-1120. doi: 10.1016/S1474-4422(18)30336-3. Epub 2018 Oct 26.

  PMID: 30509695 BACKGROUND

• Mochmann HC, Scheitz JF, Petzold GC, Haeusler KG, Audebert HJ, Laufs U, Schneider C, Landmesser U, Werner N, Endres M, Witzenbichler B, Nolte CH; TRELAS Study Group. Coronary Angiographic Findings in Acute Ischemic Stroke Patients With Elevated Cardiac Troponin: The Troponin Elevation in Acute Ischemic Stroke (TRELAS) Study. Circulation. 2016 Mar 29;133(13):1264-71. doi: 10.1161/CIRCULATIONAHA.115.018547. Epub 2016 Mar 1.

  PMID: 26933082 BACKGROUND

• Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.

  PMID: 27403291 BACKGROUND

• Stengl H, Ganeshan R, Hellwig S, Blaszczyk E, Fiebach JB, Nolte CH, Bauer A, Schulz-Menger J, Endres M, Scheitz JF. Cardiomyocyte Injury Following Acute Ischemic Stroke: Protocol for a Prospective Observational Cohort Study. JMIR Res Protoc. 2021 Feb 5;10(2):e24186. doi: 10.2196/24186.

  PMID: 33544087 BACKGROUND

• Scheitz JF, Stengl H, Nolte CH, Landmesser U, Endres M. Neurological update: use of cardiac troponin in patients with stroke. J Neurol. 2021 Jun;268(6):2284-2292. doi: 10.1007/s00415-020-10349-w. Epub 2020 Dec 29.

  PMID: 33372247 BACKGROUND

• Rosso M, Stengl H, Ganeshan R, Hellwig S, Klammer MG, von Rennenberg R, Bohme S, Nolte CH, Audebert HJ, Endres M, Kasner SE, Scheitz JF. Sex Differences in Outcomes of Acute Myocardial Injury After Stroke. J Am Heart Assoc. 2024 Mar 5;13(5):e032755. doi: 10.1161/JAHA.123.032755. Epub 2024 Feb 27.

  PMID: 38410952 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Myocardial Stunning; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia

Study Officials

• Jan Scheitz, PD Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinician Scientist

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)