Myocardial InfarctionACS-COVIDNCT05732597
Acute Coronary Syndrome in Patients With COVID-19
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by Bulgarian Cardiac Institute at 1 site in Bulgaria.
Trial summary
The aim of this study was to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with myocardial infarction (MI), who have an infarct-related artery (IRA) and therefore, require immediate revascularization, and those, who have no IRA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome, COVID-19
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Nov 2020to 27 Feb 2022
- 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: Every patient above 18 years old with ACS and COVID-19 infection
Who may be able to join
- Acute coronary syndrome (ACS)
- COVID-19 infection
Who cannot join
- No combination of ACS and COVID-19 infection
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Heart and brain center of clinical excellence, University hospita, Pleven, Bulgaria
Pleven, 5800
About this study
Official title: How to Decide Which COVID-19 Patient With Myocardial Infarction to Send to the Cath Lab? - A Case Series of COVID-19 Patients With Myocardial Infarction
The aim of this study was to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with myocardial infarction (MI), who have an infarct-related artery (IRA) and therefore, require immediate revascularization, and those, who have no IRA.
Read the detailed description
The coronavirus pandemic has hit the world with its vast contagiousness, high morbidity, and mortality Apart from the direct damage to the lung tissue, the corona virus infection is associated with multiple organ damage, including the heart. Emerging evidence reveals a direct correlation between COVID-19 and cardiovascular complications, such as heart failure, myocarditis, arrhythmias, conduction abnormalities and acute coronary syndromes. The SARS-CoV-2 infection can frequently induce coagulation abnormalities that are associated with cardiopulmonary deterioration and death as a possible complication in all patients, despite presence or absence of concomitant risk factors and diseases. In addition, many patients with severe COVID-19 undergo thromboembolic events, which seem to be related to this particular coagulopathy. One of the most unpleasant and life-threatening types of thromboembolism is the one involving the coronary circulation, thus causing a heart attack. Many additional problems arise due to this condition e.g., access to a Cath lab, exposure of additional medical personnel, more complications and increased mortality for the patients.
Invasive angiography for COVID-19 patients is logistically challenging and, in some cases, there is no intervention target, since microcirculatory disease and thrombosis is common in this group. Therefore, the investigators studied in detail the case series of 10 patients referred for primary percutaneous coronary intervention (pPCI) for MI in our catheterization laboratory during the course of COVID-19 infection. And the investigators set themselves the purpose to evaluate if there are some factors or parameters that could predict the presence of an interventional target - infarct related artery (IRA), prior to catheterization, and to determine their sensitivity and specificity.
- Being tested
- Coronary angiography
- Keywords
- COVID-19, Coronavirus, Acute coronary syndrome, Troponin
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, COVID-19, Wounds and Injuries, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
A coronary angiogram is a procedure that uses X-ray imaging to see the patient's blood vessels of the heart. The test is generally done to see if there's a restriction in blood flow going to the heart.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ACS and no IRA | Patients with acute coronary syndrome (ACS) during a COVID-19 infection, who after undergoing coronary angiography - no infarct-related artery (IRA) is found Receives: Procedure: Coronary angiography | |
| Patients with ACS and IRA | Patients with acute coronary syndrome (ACS) during a COVID-19 infection, who after undergoing coronary angiography - an infarct-related artery (IRA) is found Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with MI and IRA and those, who have no IRA
Measured: During the whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Nov 2020
- Primary completion27 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulgarian Cardiac Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732597
- Sponsor's protocol ID
- 1
- Acronym
- ACS-COVID
- Status last verified
- Aug 2024
- First submitted
- 16 Feb 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Decide Which COVID-19 Patient With Myocardial Infarction to Send to the Cath Lab? - A Case Series of COVID-19 Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05732597
- Acronym / sponsor ID
- ACS-COVID / 1
- Keywords
- COVID-19, Coronavirus, Acute coronary syndrome, Troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bulgarian Cardiac InstituteResearch network
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 17 Feb 2023 (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.
The aim of this study was to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with myocardial infarction (MI), who have an infarct-related artery (IRA) and therefore, require immediate revascularization, and those, who have no IRA.
Detailed description
The coronavirus pandemic has hit the world with its vast contagiousness, high morbidity, and mortality Apart from the direct damage to the lung tissue, the corona virus infection is associated with multiple organ damage, including the heart. Emerging evidence reveals a direct correlation between COVID-19 and cardiovascular complications, such as heart failure, myocarditis, arrhythmias, conduction abnormalities and acute coronary syndromes. The SARS-CoV-2 infection can frequently induce coagulation abnormalities that are associated with cardiopulmonary deterioration and death as a possible complication in all patients, despite presence or absence of concomitant risk factors and diseases. In addition, many patients with severe COVID-19 undergo thromboembolic events, which seem to be related to this particular coagulopathy. One of the most unpleasant and life-threatening types of thromboembolism is the one involving the coronary circulation, thus causing a heart attack. Many additional problems arise due to this condition e.g., access to a Cath lab, exposure of additional medical personnel, more complications and increased mortality for the patients.
Invasive angiography for COVID-19 patients is logistically challenging and, in some cases, there is no intervention target, since microcirculatory disease and thrombosis is common in this group. Therefore, the investigators studied in detail the case series of 10 patients referred for primary percutaneous coronary intervention (pPCI) for MI in our catheterization laboratory during the course of COVID-19 infection. And the investigators set themselves the purpose to evaluate if there are some factors or parameters that could predict the presence of an interventional target - infarct related artery (IRA), prior to catheterization, and to determine their sensitivity and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ACS and no IRA | – | Procedure: Coronary angiographyPatients with acute coronary syndrome (ACS) during a COVID-19 infection, who after undergoing coronary angiography - no infarct-related artery (IRA) is found |
| Patients with ACS and IRA | – | Procedure: Coronary angiographyPatients with acute coronary syndrome (ACS) during a COVID-19 infection, who after undergoing coronary angiography - an infarct-related artery (IRA) is found |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient above 18 years old with ACS and COVID-19 infection
Key inclusion criteria (2 listed)
- Acute coronary syndrome (ACS)
- COVID-19 infection
Key exclusion criteria (1 listed)
- No combination of ACS and COVID-19 infection
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 |
|---|---|---|
| Coronary angiographyA coronary angiogram is a procedure that uses X-ray imaging to see the patient's blood vessels of the heart. The test is generally done to see if there's a restriction in blood flow going to the heart. | Procedure or surgery | Patients with ACS and IRA, Patients with ACS and no IRA |
Primary outcome
to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with MI and IRA and those, who have no IRA
Time frame: During the whole study
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 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Infarction and Acute Coronary Syndrome, run by Bulgarian Cardiac Institute at 1 site in Bulgaria.
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 2 inclusion and 1 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 Aug 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 Bulgaria. 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?
to find a clinical or laboratory parameter, that would help in distinguishing between COVID-19 patients with MI and IRA and those, who have no IRA (time frame: During the whole study). 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 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.