Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID

NCT ID: NCT06427512

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-03-31

Brief Summary

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AIM 1. Characterize cardiovascular phenotypes of long COVID by cardiopulmonary, meta-bolic, and cardiac mechanical/physiological responses to exercise and microvascular vasomotor function.

AIM 2. Identify intercellular signaling between immune cells and cardiac cells associated with microvascular phenotypes of long COVID.

Detailed Description

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As many as 40-60% of patients who recovered from mild or moderate acute COVID have reported what is now called long COVID - multiple, persistent or recurrent symptoms lasting 6-9 months (or longer) following initial illness.1-4 Fatigue, dyspnea, and chest pain are the most common symptoms. Others include palpitations, lightheadedness, and syncope. All these cardiovascular symptoms can be debilitating, resulting in worse quality of life and morbidity.5, 6 Treatment options are limited.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID patients

Patients with long COVID-19 and experiencing cardiovascular symptoms at 24 weeks post-acute illness or post-COVID without cardiovascular symptoms by 8 weeks after illness.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18, \< 75 yrs
* History of lab-confirmed COVID
* Symptomatic at \>12 wks post-acute COVID (cases)
* Recovered by 8wks post-acute COVID (controls)

Exclusion Criteria

* Any history of critical illness
* Chronic kidney disease, Stage \>4
* Pre-COVID: HFrEF, CABG, arrhythmia; pulmonary hypertension, pulmonary embolus, interstitial lung disease (ILD), O2 dependence; dementia, stroke, autonomic dysfunction; coagulopathy
* Post-COVID: ILD, O2 dependence
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology

Locations

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CUIMC

New York, New York, United States

Site Status

Countries

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United States

References

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Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23.

Reference Type BACKGROUND
PMID: 34163090 (View on PubMed)

Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.

Reference Type BACKGROUND
PMID: 33284676 (View on PubMed)

Nehme M, Braillard O, Chappuis F, Courvoisier DS, Guessous I; CoviCare Study Team. Prevalence of Symptoms More Than Seven Months After Diagnosis of Symptomatic COVID-19 in an Outpatient Setting. Ann Intern Med. 2021 Sep;174(9):1252-1260. doi: 10.7326/M21-0878. Epub 2021 Jul 6.

Reference Type BACKGROUND
PMID: 34224254 (View on PubMed)

Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.

Reference Type BACKGROUND
PMID: 34951953 (View on PubMed)

Huang L, Yao Q, Gu X, Wang Q, Ren L, Wang Y, Hu P, Guo L, Liu M, Xu J, Zhang X, Qu Y, Fan Y, Li X, Li C, Yu T, Xia J, Wei M, Chen L, Li Y, Xiao F, Liu D, Wang J, Wang X, Cao B. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021 Aug 28;398(10302):747-758. doi: 10.1016/S0140-6736(21)01755-4.

Reference Type BACKGROUND
PMID: 34454673 (View on PubMed)

Sigfrid L, Drake TM, Pauley E, Jesudason EC, Olliaro P, Lim WS, Gillesen A, Berry C, Lowe DJ, McPeake J, Lone N, Munblit D, Cevik M, Casey A, Bannister P, Russell CD, Goodwin L, Ho A, Turtle L, O'Hara ME, Hastie C, Donohue C, Spencer RG, Donegan C, Gummery A, Harrison J, Hardwick HE, Hastie CE, Carson G, Merson L, Baillie JK, Openshaw P, Harrison EM, Docherty AB, Semple MG, Scott JT; ISARIC4C investigators. Long Covid in adults discharged from UK hospitals after Covid-19: A prospective, multicentre cohort study using the ISARIC WHO Clinical Characterisation Protocol. Lancet Reg Health Eur. 2021 Sep;8:100186. doi: 10.1016/j.lanepe.2021.100186. Epub 2021 Aug 6.

Reference Type BACKGROUND
PMID: 34386785 (View on PubMed)

Other Identifiers

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AAA-TBA

Identifier Type: -

Identifier Source: org_study_id

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