Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors

Официальное название

Cardiac Magnetic Resonance for Tissue Characterization-Based Risk Stratification of Cardiopulmonary Symptoms, Effort Tolerance, and Prognosis Among COVID-19 Survivors

Обзор

The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be important in the understanding cardiac function and prediction of cardiopulmonary symptoms, physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research will allow us to identify the causes of lasting cardiopulmonary symptoms and begin developing cardiac and lung directed therapies accordingly.

Подробное описание

Coronavirus disease 2019 (COVID-19) is an ongoing global pandemic. Despite substantial short term mortality risk, the overwhelming majority of infected patients survive acute illness, resulting in a growing population at risk for long term events. Cardiopulmonary symptoms are common after COVID-19, as shown by survey data reporting fatigue (53%), dyspnea (43%), and worsened quality of life (44%) 60 days after acute infection, but mechanism and time course of symptoms are unknown. Recent studies and the investigator's preliminary data have shown myocardial tissue abnormalities on cardiac magnetic resonance (CMR) to be common in COVID-19 survivors - raising the possibility that symptoms stem from viral effects on the heart. However, CMR findings to date are limited by small size and clinical data susceptible to referral bias, raising uncertainty as to generalizability. It is also unknown whether altered myocardial tissue properties (fibrosis, edema) impact clinical outcomes.

The central hypothesis of the research is that CMR tissue characterization will be incremental to clinical assessment and cardiac contractile function for prediction of long-term cardiopulmonary symptoms, effort tolerance, and prognosis among COVID-19 survivors. To test this, the investigators will study patients from an active multiethnic New York City registry of COVID-19 survivors: the investigators have already leveraged echocardiographic imaging data from this registry to show that (1) adverse cardiac remodeling (dilation, dysfunction) markedly augments short term mortality, (2) COVID-19 acutely alters left and right ventricular remodeling, and (3) many patients who survive initial hospitalization for COVID-19 have adverse cardiac remodeling - including 40% with left ventricular (LV) dysfunction and 32% with adverse RV remodeling (dilation, dysfunction): the investigator's current proposal will extend logically on the preliminary data to test whether CMR tissue characterization provides incremental predictive utility with respect to reverse remodeling and prognosis. At least 510 COVID-19 survivors will be studied. Echo will be analyzed at time of and following COVID-19 for longitudinal remodeling, as will CMR at pre-specified (6-12, 36 month) follow-up timepoints. Established and novel CMR technologies will be employed, including assessment of cardiac and lung injury, high resolution (3D) myocardial tissue characterization, and cardiopulmonary blood oxygenation. In parallel, QOL, effort tolerance (6-minute walk test), biomarkers, and rigorous follow-up will be obtained to discern clinical implications and relative utility of imaging findings. Aim 1 will identify determinants of impaired quality of life and effort intolerance among COVID-19 survivors. Aim 2 will test whether myocardial tissue injury on CMR is associated with impaired contractility, and whether fibrosis predicts contractile recovery. Aim 3 will determine whether myocardial tissue injury is independently associated with adverse prognosis (new onset clinical heart failure, hospitalization, mortality). Results will address key knowledge gaps regarding COVID-19 effects on the heart necessary to guide surveillance, risk stratification, and targeted therapies for millions of COVID-19 survivors at risk for myocardial injury, cardiopulmonary symptoms, and adverse prognosis.

Вмешательства

• Диагностический тест Cardiac MRI
  Patients participate in an NIH funded cardiac MRI to assess their symptoms.
• Диагностический тест Echocardiogram
  Patients participate in an NIH funded cardiac echocardiogram to assess their symptoms.
• Диагностический тест 6-minute walk test
  Patients participate in a 6-minute walk test to assess their symptoms.
• Диагностический тест Questionnaire
  Patients answer a survey-based questionnaire to assess their symptoms.

Первичные конечные точки

• Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) > 3 months post-COVID-19 (coronavirus disease 2019) diagnosis, at first study visit [Срок оценки: Day of first study visit, > 3 months post acute COVID-19 infection]
• Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit [Срок оценки: 12-36 months post first study visit]
• Blood oxygenation of participants at > 3 months post-COVID-19 diagnosis, first study visit [Срок оценки: Day of first study visit, > 3 months post- acute COVID-19 infection]
• Blood oxygenation of participants at 12-36 months post first study visit [Срок оценки: 12-36 months post first study visit]
• Lung abnormalities in participants at > 3 months post-COVID-19 infection [Срок оценки: Day of first study visit, > 3 months post- acute COVID-19 infection]
• Lung abnormalities in participants at 12-36 months post first study visit [Срок оценки: 12-36 months post first study visit]
• Quality of life (QOL) in participants at > 3 months post-COVID-19 diagnosis, at first study visit based on clinical indices and symptoms assessed by the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire. [Срок оценки: Day of first study visit, > 3 months post- acute COVID-19 infection]
• Quality of life (QOL) in participants at 12-36 months post first study visit based on clinical indices and symptoms assessed by the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire. [Срок оценки: 12-36 months post first study visit]
• Effort tolerance as measured by a 6-minute walk test at > 3 months post-COVID-19 diagnosis, at first study visit [Срок оценки: Day of first study visit, > 3 months post- acute COVID-19 infection]
• Effort tolerance as measured by a 6-minute walk test at 12-36 months post first study visit [Срок оценки: 12-36 months post first study visit]

Критерии участия

Критерии включения

• Emergency room presentation and/or hospitalization with COVID-19 infection defined in accordance with established criteria as follows: SAR-CoV2 RT-PCR+ (severe acute respiratory syndrome coronavirus 2 reverse transcription polymerase chain reaction) and at least one of the following symptoms: dyspnea, cough, dysphagia, rhinorrhea, diarrhea, nausea/vomiting, myalgias, fever, syncope/presyncope.

Критерии исключения

• Contraindication to CMR (i.e. non-compatible pacemaker/defibrillator) or gadolinium (known hypersensitivity, eGFR (estimated globular filtration rate) <30 ml/min/1.73m2).
• Inability to provide informed consent (e.g. cognitive impairment).
• Unrelated condition (e.g. neoplasm) with life expectancy <12 months prohibiting follow-up.
• Patients with contraindications to gadolinium (known or suspected hypersensitivity, glomerular filtration rate < 30 ml/min/1.73m2) will undergo non-contrast MRI but will not be excluded from this study.
• Patients with known or suspected pregnancy based on Weill Cornell Radiology intake surveys (reviewed by a clinical RN (registered nurse), as well as research personnel) will be excluded from the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• New York Presbyterian-Brooklyn Methodist Hospital — Brooklyn
• New York Presbyterian Queens — New York
• Weill Cornell Medicine/New-York Presbyterian Hospital — New York

Идентификаторы

NCT: NCT05164744 · 21-02023362 · R01HL159055-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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