Covid19NCT04661657
COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry
An observational study of Covid19 and Cardiac Disease, run by Columbia University at 1 site in United States.
Trial summary
COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Cardiac Disease, Cardiac Arrhythmia
- What is being tested?
- Transthoracic echocardiogram (TTE) and Cardiovascular Magnetic Resonance (CMR) Imaging
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 22 Jan 2022
- How long will I take part?
- 2 Days
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 18 years of age or older, without cardiac disease who have tested positive for COVID-19 or healthy control subjects who have not had COVID-19. Willing to undergo Cardiac MRI and Transthoracic echocardiogram. No known sensitivity to Gadolinium based contrast agent.
Who may be able to join
- Convalescent COVID-19 patient
- If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.
- Control patients who have had a negative COVID-19 screening without prior positive tests.
- Willingness to undergo Clariscan-enhanced CMR scan.
- Ability to hold breath for 15 seconds.
- Willingness to give informed consent.
- Greater than or equal to 18 years of Age.
Who cannot join
- Subjects who are Pregnant or nursing
- Severe valvular heart disease
- History of congestive heart failure preceding COVID-19
- History of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8
- Contraindication to MRI
- Known allergy to gadoterate
Show all 9Show fewer
- Estimated glomerular filtration rate <30 ml/min/1.73m2
- History of receiving more than 2 doses of a gadolinium-based contrast agent
- Subject is of prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.
Read the detailed description
This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.
CMR offers the unique ability to comprehensively characterize myocardial tissue and assess the heart's structure and function, through a variety of complementary imaging techniques using different pulse sequences. The investigators propose to provide a multi-sequence CMR evaluation of a spectrum of convalescent COVID-19 patients, compare COVID-19 survivors to controls, and study the relationships between myocardial characteristics by CMR and echocardiography and health outcomes, and how these are modulated through patient characteristics, and clinical characteristics of COVID-19 illness. Broadly, this myocardial characterization will not just provide diagnosis but serve as a potentially powerful tool for risk stratification, therapeutic decision making, and monitoring response to therapies in COVID-19 survivors.
Transthoracic echocardiography (TTE) is the most widely used imaging technique for the assessment of cardiac morphology and function. While its capability for myocardial tissue characterization is inferior to that of CMR, TTE provides several advantages that make it an ideal complement to CMR for the assessment of cardiac involvement in COVID-19 patients. TTE offers a rapid noninvasive evaluation of myocardial and valvular function, in addition to the assessment of other cardiac abnormalities of interest (such as presence and amount of pericardial effusion) and important hemodynamic variables (noninvasive estimation of pulmonary pressures is an example). TTE is easily performed and reproducible, and does not involve the use of radiations or contrast agents, which allows the performance of repeat evaluations to assess serial changes over time in the cardiac parameters of interest.
- Being tested
- Transthoracic echocardiogram (TTE), Cardiovascular Magnetic Resonance (CMR) Imaging
- Medical subject headings
- COVID-19, Heart Diseases, Arrhythmias, Cardiac, Myocarditis, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogram (TTE)Other
Subjects will undergo TTE imaging.
Cardiovascular Magnetic Resonance (CMR) ImagingOther
Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Non-prisoner and non-pregnant subjects, without prior cardiac disease, who have tested positive or have been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA). Receives: Other: Transthoracic echocardiogram (TTE); Other: Cardiovascular Magnetic Resonance (CMR) Imaging | |
| Control | Non-prisoner and non-pregnant subjects, without prior cardiac disease, who have never tested positive and/or has never been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA). Receives: Other: Transthoracic echocardiogram (TTE); Other: Cardiovascular Magnetic Resonance (CMR) Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of myocardium demonstrating late gadolinium enhancement
Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.
Measured: Up to 2 hours
Extracellular Volume (ECV) Fraction
Extracellular volume fraction measured by CMR imaging. ECV determined using Circle cvi42 software and using formula ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)).
Measured: Up to 2 hours
Left Ventricular Ejection Fraction
Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start28 Dec 2020
- Primary completion22 Jan 2022
- Study completion22 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Andrew J. Einstein, MD, PhD, Principal investigator, Columbia Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661657
- Sponsor's protocol ID
- AAAT0787
- Status last verified
- Jun 2022
- First submitted
- 8 Dec 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
- ClinicalTrials.gov ID
- NCT04661657
- Acronym / sponsor ID
- AAAT0787
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 10 Dec 2020 (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.
COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.
Detailed description
This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.
CMR offers the unique ability to comprehensively characterize myocardial tissue and assess the heart's structure and function, through a variety of complementary imaging techniques using different pulse sequences. The investigators propose to provide a multi-sequence CMR evaluation of a spectrum of convalescent COVID-19 patients, compare COVID-19 survivors to controls, and study the relationships between myocardial characteristics by CMR and echocardiography and health outcomes, and how these are modulated through patient characteristics, and clinical characteristics of COVID-19 illness. Broadly, this myocardial characterization will not just provide diagnosis but serve as a potentially powerful tool for risk stratification, therapeutic decision making, and monitoring response to therapies in COVID-19 survivors.
Transthoracic echocardiography (TTE) is the most widely used imaging technique for the assessment of cardiac morphology and function. While its capability for myocardial tissue characterization is inferior to that of CMR, TTE provides several advantages that make it an ideal complement to CMR for the assessment of cardiac involvement in COVID-19 patients. TTE offers a rapid noninvasive evaluation of myocardial and valvular function, in addition to the assessment of other cardiac abnormalities of interest (such as presence and amount of pericardial effusion) and important hemodynamic variables (noninvasive estimation of pulmonary pressures is an example). TTE is easily performed and reproducible, and does not involve the use of radiations or contrast agents, which allows the performance of repeat evaluations to assess serial changes over time in the cardiac parameters of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: Transthoracic echocardiogram (TTE), Other: Cardiovascular Magnetic Resonance (CMR) ImagingNon-prisoner and non-pregnant subjects, without prior cardiac disease, who have tested positive or have been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA). |
| Control | – | Other: Transthoracic echocardiogram (TTE), Other: Cardiovascular Magnetic Resonance (CMR) ImagingNon-prisoner and non-pregnant subjects, without prior cardiac disease, who have never tested positive and/or has never been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age or older, without cardiac disease who have tested positive for COVID-19 or healthy control subjects who have not had COVID-19. Willing to undergo Cardiac MRI and Transthoracic echocardiogram. No known sensitivity to Gadolinium based contrast agent.
Key inclusion criteria (7 listed)
- Convalescent COVID-19 patient
- If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.
- Control patients who have had a negative COVID-19 screening without prior positive tests.
- Willingness to undergo Clariscan-enhanced CMR scan.
- Ability to hold breath for 15 seconds.
Key exclusion criteria (9 listed)
- Subjects who are Pregnant or nursing
- Severe valvular heart disease
- History of congestive heart failure preceding COVID-19
- History of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiogram (TTE)Subjects will undergo TTE imaging. | Other | COVID-19, Control |
| Cardiovascular Magnetic Resonance (CMR) ImagingSubjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA). | Other | COVID-19, Control |
Primary outcome
Percentage of myocardium demonstrating late gadolinium enhancement
Time frame: Up to 2 hours
Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.
Extracellular Volume (ECV) Fraction
Time frame: Up to 2 hours
Extracellular volume fraction measured by CMR imaging. ECV determined using Circle cvi42 software and using formula ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)).
Left Ventricular Ejection Fraction
Time frame: Up to 2 hours
Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Andrew J. Einstein, MD, PhD principal investigator
Columbia Univeristy
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 Covid19 and Cardiac Disease, 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of myocardium demonstrating late gadolinium enhancement (time frame: Up to 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2022.