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Myocardial InjuryMIDAVAXNCT05359250

Myocardial Injury and Dysfunction Associated With COVID-19 Vaccination

An observational study of Myocardial Injury and COVID-19, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of the study is to investigate the characteristics and potential mechanisms responsible for myocardial injury and dysfunction in patients after COVID-19 vaccination. Cardiac damage will be assessed with cardiac MRI and endomyocardial biopsy (EmBx) histopathology. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Injury, COVID-19, Vaccine Reaction
Type of treatment
Vaccines
How many people
10 participants
Where
1 siteUnited States
Study dates
12 May 2021to 30 Dec 2024
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Ten patients with new symptoms of chest discomfort and biomarkers of myocardial injury that occurred 2-10 days following SARS-CoV-2 mRNA vaccination will be recruited up to 180 days following diagnosis. Patients will have no other known etiology for myocardial injury other than recent mRNA COVID vaccine exposure. Patients may be referred from inpatient or outpatient settings, from across the UCHealth system, but will be recruited in-person at University of Colorado Hospital.

Who may be able to join

  • age ≥18 years;
  • clear evidence of myocardial involvement including:
  • High Sensitivity Troponin I value of (≥0.05 ng/ml (the 99% upper bound)) OR
  • an LVEF < 50% OR
  • ST-T change suggesting STEMI, NSTEMI or myopericarditis in the absence of coronary artery disease, OR
  • new onset sustained VT or VF
Show all 10Show fewer
  • Late gadolinium enhancement or edema on cMRI consistent with myocardial injury or inflammation.
  • Documentation of vaccination with mRNA-based COVID-19 vaccine.
  • No history of COVID-19, or a negative SARS-CoV-2 PCR or other FDA approved laboratory test within 1 week of enrollment.
  • Patient and/or legally authorized representative must be competent to understand and agree with informed consent form.

Who cannot join

  • Hemodynamic instability as evidenced by escalating doses of inotropic agents or vasopressors within the prior 24 hours
  • Respiratory instability as evidenced by increasing oxygen requirements over the 24 hours prior to consent or FiO2 requirement ≥ 60 %.
  • evidence that respiratory failure is the primary reason for myocardial dysfunction;
  • Moderate to severe pulmonary hypertension (mean PAP ≥35 mmHg);
  • INR >1.8 on no anticoagulation or contraindication to withdrawing anticoagulation;
  • platelets <100,000/mm3.
  • History of laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) testing or other commercial or public health assay.
  • Acute or chronic kidney disease with glomerular filtration rate < 30 ml/min.1.72m2

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Evaluation of Myocardial Dysfunction Due to mRNA-based SARS-CoV-2 Vaccines

The overall goal of the study is to investigate the characteristics and potential mechanisms responsible for myocardial injury and dysfunction in patients after COVID-19 vaccination. Cardiac damage will be assessed with cardiac MRI and endomyocardial biopsy (EmBx) histopathology. Myocardial gene expression will be measured in RNA extracted from EmBxs mRNA abundance compared to nonfailing and failing control hearts.

Read the detailed description

To determine whether there is microvascular thrombosis-associated myocardial damage and dysfunction vs. inflammation or other changes in patients who, following administration of SARS-CoV-2 mRNA vaccine, develop evidence of myocardial injury typically diagnosed as "myocarditis" based on cardiac MRI findings.

Further, the degree of inflammatory reaction vs. microthrombotic injury to cardiac myocytes from biopsied myocardial tissue will be compared with biopsied myocardial tissue from control hearts. mRNA expression of the ACE2 and ITGA5 binding targets of SARS-Cov-2 Spike protein encoded by mRNA vaccines, as well as expression of other genes that may contribute to post-vaccine pro-thrombotic and pro-inflammatory states including Coagulation Factor 3 (F3, also known as tissue factor), ACE, AGTR1 and AGT) or a dysfunctional cardiac state (NPPB as a marker of pathologic remodeling) will be examined as candidate genes. Additional, global gene expression is being measured by RNA-Seq and microarray.

Keywords
COVID-19, mRNA vaccines, myocardial injury, myocarditis, gene expression
Medical subject headings
COVID-19, Myocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05359250
Study groupRoleWhat they receive
Patients with evidence of myocardial injury related to vaccination with a SARS-CoV-2 mRNA vaccinePatients who present with new symptoms of chest pain within 2-10 days following SARS-CoV-2 mRNA vaccination will be recruited up to 180 days following diagnosis. Patients will be screened using multiple methods and then provided informed consent. If patients are unable to consent, health care decision makers of patients who meet initial inclusion criteria will be approached for consent. Following informed consent, a cardiac MRI will be performed (if not performed prior) to assess myocardial function and potential damage. Patients will qualify on the basis of the presence of late-gadolinium enhancement and/or abnormal T1 mapping on MRI. The patient will then be taken to the cardiac catheterization lab where he/she will undergo endomyocardial biopsy and right heart catheterization (RHC) for candidate gene analysis. A blood sample will be collected to analyze circulating biomarkers associated with myocardial injury.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial damage

    Initial clinical diagnosis of myocardial injury or myocarditis will be confirmed by cardiac MRI. Specific findings of late gadolinium enhancement and abnormal T1-signals within the myocardium consistent with acute injury, inflammation or edema will be evaluated.

    Measured: clinical follow up for at least 30 days following endomyocardial biopsy

  2. Histopathological changes assessed by light- and electron-microscopy in myocardial tissue

    Determining the histopathologic changes present in the endomyocardial biopsies of patients with COVID-19 vaccine-induced myocardial injury. Assessment of the standard H\&E stains will include evaluation for presence and degree of inflammation within the myocardium, presence of microvascular thrombi within vasculature, and evidence of myocardial damage. The trichrome, iron, and Congo red stains will be used to evaluate for the presence of fibrosis, iron, or amyloid, respectively. Electron microscopy will be employed to examine cardiac myocyte and small blood vessel architectures.

    Measured: clinical follow up for at least 30 days following endomyocardial biopsy

  3. Myocardial mRNA expression

    Measure myocardial mRNA expression of candidate genes involved in Spike protein binding and cell entry (ACE2 and ITGA5), the renin-angiotensin system (ACE, AGT, AGTR1), initiation of coagulation (F3/TF) and pathologic myocardial remodeling (NPPB).

    Measured: clinical follow up for at least 30 days following endomyocardial biopsy

Secondary outcomes (1)

  1. Myocardial mRNA expression of additional genes measured by both RNA-Seq and microarray.

    Measure mRNA expression of additional candidate and global genes, and compare results to nonfailing and failing controls. Seven candidate genes will be measured by three platforms (qPCR, RNA-Seq and microarray), and global transcripts by RNA-Seq and microarray.

    Measured: clinical follow up for at least 30 days following endomyocardial biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start12 May 2021
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359250
Sponsor's protocol ID
21-4055
Other IDs
3UM1AI068614-14S1
Acronym
MIDAVAX
Status last verified
Apr 2025
First submitted
2 May 2022
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Patone M, Mei XW, Handunnetthi L, Dixon S, Zaccardi F, Shankar-Hari M, Watkinson P, Khunti K, Harnden A, Coupland CAC, Channon KM, Mills NL, Sheikh A, Hippisley-Cox J. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022 Feb;28(2):410-422. doi: 10.1038/s41591-021-01630-0. Epub 2021 Dec 14.

    PubMed 34907393

  • Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. doi: 10.1001/jama.2021.24110.

    PubMed 35076665

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Injury and COVID-19, run by University of Colorado, Denver 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 10 inclusion and 8 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 4 Apr 2025. 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?

Myocardial damage (time frame: clinical follow up for at least 30 days following endomyocardial biopsy). 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?

On the ClinicalTrials.gov record for NCT05359250, which also lists 2 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 4 Apr 2025.

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