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

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..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 22. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Acute Lung Injury Bronchitis COVID-19 Communicable Diseases Coronavirus Infections Infections Recruitment Status: Recruiting Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Infections Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: December 21, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024

Study ID:	NCT05164744 21-02023362 R01HL159055-01
Veröffentlichungen zur Studie:

fisyears:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	CTG000136301