COVID-19NCT06427512
Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID
An observational study of COVID-19, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- COVID-19
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- Adult, Older adult
Study population: The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC).
Who may be able to join
- Age > 18, < 75 yrs
- History of lab-confirmed COVID
- Symptomatic at >12 wks post-acute COVID (cases)
- Recovered by 8wks post-acute COVID (controls)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies
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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- long COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Microvascular dysfunction
This is to measure the microvascular dysfunction in patients using Cardiac PET.
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Emily Tsai, MD, Principal investigator, Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427512
- Sponsor's protocol ID
- AAA-TBA
- Status last verified
- May 2024
- First submitted
- 1 Feb 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34163090Nehme 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.
PubMed 33284676Nehme 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.
PubMed 34224254Soriano 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.
PubMed 34951953Huang 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.
PubMed 34454673Sigfrid 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.
PubMed 34386785
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies
- ClinicalTrials.gov ID
- NCT06427512
- Acronym / sponsor ID
- AAA-TBA
- Conditions
- COVID-19
- Keywords
- long COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC).
Key inclusion criteria (4 listed)
- Age > 18, < 75 yrs
- History of lab-confirmed COVID
- Symptomatic at >12 wks post-acute COVID (cases)
- Recovered by 8wks post-acute COVID (controls)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Microvascular dysfunction
Time frame: Up to 2.5 years
This is to measure the microvascular dysfunction in patients using Cardiac PET.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 34163090Blomberg 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.
- Background: PubMed 33284676Nehme 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.
- Background: PubMed 34224254Nehme 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.
- Background: PubMed 34951953Soriano 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.
- Background: PubMed 34454673Huang 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.
- Background: PubMed 34386785Sigfrid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Tsai, MD principal investigator
Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Microvascular dysfunction (time frame: Up to 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427512, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.