Clinical trial NCT06427512: Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID
Official title: Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19
Keywords: long COVID-19
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC).

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Microvascular dysfunction
timeFrame: Up to 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: CUIMC
state: New York
Study officials:
affiliation: Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology
name: Emily Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.