Cardiovascular DiseasesNCT04430374
Registry for a Cardiovascular Patient Who COVID-19 Infection in Qatar and Gulf
An observational study of Cardiovascular Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted in a global pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- No interverntion
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 2 Jun 2020to 31 Dec 2020
- How long will I take part?
- 1 Week
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: (1) Retrospective data for all patients since the COVID-19 appear in Qatar unit the prospective arm gets started after approval(2) Prospective data starting from the date of submission of this protocol and forward and all patients will be followed up for long-term outcome(3) Retrospective data for all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared to previous years to report the trends of acute cardiovascular conditions in the COVID era to previous data, as a lot of countries documented decrease in the incidence.
Who may be able to join
- Patients who admitted to the heart hospital or any other hospital with acute cardiovascular condition.
- Patient with confirming or suspicious of COVID-19 infection
- Patient who admitted to any hospital in the Gulf and has Acute MI with confirm or suspicious of COVID-19 infection
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, Unlisted (UL), 974
DR.Jassim Alsuwaidi Senior Consultant, 44395392, jalsuwaidi@hamad.qa
About this study
Official title: Qatar Cardiovascular COVID-19 Registry
The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted in a global pandemic. This infection has a special implication on the patient who complains from cardiac disease or acute cardiovascular condition and may result in cardiovascular complications such as myocardial infarction. For this end, we target to study this group of patient, who has a cardiac disease with COVID-19 in Qatar, in addition, the acute myocardial infarction with COVID-19 from the Gulf countries and collect all the related data to come with a comprehensive view about those patients.
Read the detailed description
The primary objective of this registry is to create a database of patients who present with acute cardiovascular and are found to be COVID -19 positive (by PCR). The registry will consist of four arms (1) Retrospective data for all patients since the COVID-19 appear in Qatar unit the date of submission the protocol (2) Prospective data starting from the date of submission of this protocol and forward until end of December 2020 (3) Retrospective data for all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared to previous years to report the trends of acute cardiovascular conditions in the COVID era to previous data, as a lot of countries documented decrease in the incidence. (4) retrospective data for acute MI and found to be COVID-19 until this protocol amendment from participating hospitals in the Gulf region to be compared with Acute MI from Qatar who collected in arm 1. The registry will consist of patients admitted with AMI who were already having active COVID-19 infection or were incidentally found to have COVID-19 by PCR. Additionally, prospective data from the data of this protocol amendment until the end of December 2020. This arm target to (a) increases the number of the collected patient for Acute MI with COVID-19category due to the small number in Qatar alone. (b) give the opportunity for Qatar to lead a multicenter project to serve in a hot topic, in particular, the data collection and analysis will be in Qatar. (c) allow releasing a publication for one cardiovascular center (Qatar only) and multi-cardiovascular center (all the Gulf), a multi-center publication about this issue could be rare on the worldwide level, and finally, (d) to increase the accuracy of the data analysis due to larger data size and comparing more than one site together.
Secondary plan to compare our patients' populations and outcomes with that of other international registries such as the NACMI(US registry). The NACMI registry is a rapid collaboration of multinational societies and medical institutions with a pragmatic study design to encourage widespread participation that will enable the development of data-driven guidelines and therapies.
The subject will be patients with confirmed or suspected COVID -19 infection with the acute cardiovascular conditions at the time of presentation to the hospital or that developed while in the hospital. All the history, laboratory results, current admission data, medication, angiogram, or intervention procedure (if underwent), and any other relevant data will be collected. All the patients who are applicable for this registry and meet the inclusion criteria will be involved so the final number of the subject is not specified. All patients with the acute coronary syndrome, out of hospital cardiac arrest and arrhythmias who are found to be COVID positive and required hospitalization will be included.
The following data variables will be collected as covariates of interest: baseline demographic and clinical characteristics, laboratory data, and pattern of ST-segment elevation (diffuse, focal, with or without ST-segment depression and/or PR -segment depression) transthoracic echocardiography or point-of-care ultrasound findings, commonly used time to treatment metrics in STEMI care (door -to -balloon or door -to -needle times), angiographic characteristics, and adjunctive pharmacological and device therapies including mechanical circulatory support (MCS ).
Implications for COVID -19 positive patients Observational registries have gained traction in cardiovascular medicine as they provide important information, including benefits and potential complications of different treatments or procedures. [12] For example, consecutive enrollment of patients with well -defined entry criteria in the Chest pain -MI Registry has been a reliable source for outcome-based, a quality improvement on high -risk STEMI/NSTEMI patients. [13] Immediate access to actionable data is particularly relevant to the current expanding COVID -19 pandemic which is disproportionally affecting cardiovascular patients and healthcare workers. [14] At present, there is no data-driven consensus on the management of patients with confirmed or suspected COVID -19 infection who present with ST-segment elevation on ECG. [11,15,16] The NACMI registry will be beneficial in identifying etiology, patterns of myocardial injury, developing a risk model for cardiac complications, understanding short and long -term major adverse cardiac events, and designing clinical trials testing different treatment modalities. Therefore, the registry will include both COVID -19 positive patients and PUI with acute cardiovascular conditions. A comparison of PUI subsequently confirmed positive to those subsequently confirmed negative will provide a unique insight into the pathophysiologic mechanism of STEMI from COVID -19, including myocarditis and prothrombotic states. Comparison of patients enrolled in NACMI to propensity-matched non -COVID STEMI controls for 1 year prior will provide critical information regarding etiology, treatment strategies and clinical outcomes in the COVID -19 pandemic. As testing for COVID -19 becomes more rapid, this decision -making process is expected to evolve. Additionally, it has been reported that overall STEMI volumes have decreased in the COVID -19 era, without a clear understanding of the reasons. [17,18] It may be that patients are delaying their presentation to the hospital, potentially leading to the need for mechanical circulatory support in the acute setting, mechanical complications of STEMI, sudden death or an increased heart failure population. Additionally, if patients are presenting later in their clinical course, NACMI registry data will allow practitioners to improve care models to improve time to treatment in this unique era.
- Conditions
- Cardiovascular Diseases
- Being tested
- No interverntion
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interverntionOther
No intervention will be done, registry only
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of COVID-19 on cardiovascular patient
The outcome of this registry will be:
- entire information about the patients who admitted with COVID-19 accompany with a cardiovascular condition in Qatar.
- Additionally, a comparison will be conducted between the cardiac patient who admitted over the period February to December to December 2020 and the same category of patients over the same period of 2019 in Qatar to figure out the reason behind the dropping of the number of the patient.
- A multicenter data from the Gulf countries for Acute MI patients infected with COVID-19.
- A comparison between our patients (either in Qatar only or the entire Gulf) populations and the outcome of other international registries such as the NACMI (US registry)
Measured: 2 month from starting date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start2 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. JASSIM MOHD. AL SUWAIDI, Hamad Medical Corporation
- Investigators
- Dr.Jassim Alsuwaidi Senior Consultant, Principal investigator, HMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430374
- Sponsor's protocol ID
- MRC-05-113
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qatar Cardiovascular COVID-19 Registry
- ClinicalTrials.gov ID
- NCT04430374
- Acronym / sponsor ID
- MRC-05-113
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Jun 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.
The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted in a global pandemic. This infection has a special implication on the patient who complains from cardiac disease or acute cardiovascular condition and may result in cardiovascular complications such as myocardial infarction. For this end, we target to study this group of patient, who has a cardiac disease with COVID-19 in Qatar, in addition, the acute myocardial infarction with COVID-19 from the Gulf countries and collect all the related data to come with a comprehensive view about those patients.
Detailed description
The primary objective of this registry is to create a database of patients who present with acute cardiovascular and are found to be COVID -19 positive (by PCR). The registry will consist of four arms (1) Retrospective data for all patients since the COVID-19 appear in Qatar unit the date of submission the protocol (2) Prospective data starting from the date of submission of this protocol and forward until end of December 2020 (3) Retrospective data for all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared to previous years to report the trends of acute cardiovascular conditions in the COVID era to previous data, as a lot of countries documented decrease in the incidence. (4) retrospective data for acute MI and found to be COVID-19 until this protocol amendment from participating hospitals in the Gulf region to be compared with Acute MI from Qatar who collected in arm 1. The registry will consist of patients admitted with AMI who were already having active COVID-19 infection or were incidentally found to have COVID-19 by PCR. Additionally, prospective data from the data of this protocol amendment until the end of December 2020. This arm target to (a) increases the number of the collected patient for Acute MI with COVID-19category due to the small number in Qatar alone. (b) give the opportunity for Qatar to lead a multicenter project to serve in a hot topic, in particular, the data collection and analysis will be in Qatar. (c) allow releasing a publication for one cardiovascular center (Qatar only) and multi-cardiovascular center (all the Gulf), a multi-center publication about this issue could be rare on the worldwide level, and finally, (d) to increase the accuracy of the data analysis due to larger data size and comparing more than one site together.
Secondary plan to compare our patients' populations and outcomes with that of other international registries such as the NACMI(US registry). The NACMI registry is a rapid collaboration of multinational societies and medical institutions with a pragmatic study design to encourage widespread participation that will enable the development of data-driven guidelines and therapies.
The subject will be patients with confirmed or suspected COVID -19 infection with the acute cardiovascular conditions at the time of presentation to the hospital or that developed while in the hospital. All the history, laboratory results, current admission data, medication, angiogram, or intervention procedure (if underwent), and any other relevant data will be collected. All the patients who are applicable for this registry and meet the inclusion criteria will be involved so the final number of the subject is not specified. All patients with the acute coronary syndrome, out of hospital cardiac arrest and arrhythmias who are found to be COVID positive and required hospitalization will be included.
The following data variables will be collected as covariates of interest: baseline demographic and clinical characteristics, laboratory data, and pattern of ST-segment elevation (diffuse, focal, with or without ST-segment depression and/or PR -segment depression) transthoracic echocardiography or point-of-care ultrasound findings, commonly used time to treatment metrics in STEMI care (door -to -balloon or door -to -needle times), angiographic characteristics, and adjunctive pharmacological and device therapies including mechanical circulatory support (MCS ).
Implications for COVID -19 positive patients Observational registries have gained traction in cardiovascular medicine as they provide important information, including benefits and potential complications of different treatments or procedures. [12] For example, consecutive enrollment of patients with well -defined entry criteria in the Chest pain -MI Registry has been a reliable source for outcome-based, a quality improvement on high -risk STEMI/NSTEMI patients. [13] Immediate access to actionable data is particularly relevant to the current expanding COVID -19 pandemic which is disproportionally affecting cardiovascular patients and healthcare workers. [14] At present, there is no data-driven consensus on the management of patients with confirmed or suspected COVID -19 infection who present with ST-segment elevation on ECG. [11,15,16] The NACMI registry will be beneficial in identifying etiology, patterns of myocardial injury, developing a risk model for cardiac complications, understanding short and long -term major adverse cardiac events, and designing clinical trials testing different treatment modalities. Therefore, the registry will include both COVID -19 positive patients and PUI with acute cardiovascular conditions. A comparison of PUI subsequently confirmed positive to those subsequently confirmed negative will provide a unique insight into the pathophysiologic mechanism of STEMI from COVID -19, including myocarditis and prothrombotic states. Comparison of patients enrolled in NACMI to propensity-matched non -COVID STEMI controls for 1 year prior will provide critical information regarding etiology, treatment strategies and clinical outcomes in the COVID -19 pandemic. As testing for COVID -19 becomes more rapid, this decision -making process is expected to evolve. Additionally, it has been reported that overall STEMI volumes have decreased in the COVID -19 era, without a clear understanding of the reasons. [17,18] It may be that patients are delaying their presentation to the hospital, potentially leading to the need for mechanical circulatory support in the acute setting, mechanical complications of STEMI, sudden death or an increased heart failure population. Additionally, if patients are presenting later in their clinical course, NACMI registry data will allow practitioners to improve care models to improve time to treatment in this unique era.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Week
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- (1) Retrospective data for all patients since the COVID-19 appear in Qatar unit the prospective arm gets started after approval(2) Prospective data starting from the date of submission of this protocol and forward and all patients will be followed up for long-term outcome(3) Retrospective data for all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared to previous years to report the trends of acute cardiovascular conditions in the COVID era to previous data, as a lot of countries documented decrease in the incidence.
Key inclusion criteria (3 listed)
- Patients who admitted to the heart hospital or any other hospital with acute cardiovascular condition.
- Patient with confirming or suspicious of COVID-19 infection
- Patient who admitted to any hospital in the Gulf and has Acute MI with confirm or suspicious of COVID-19 infection
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| No interverntionNo intervention will be done, registry only | Other | – |
Primary outcome
The impact of COVID-19 on cardiovascular patient
Time frame: 2 month from starting date
The outcome of this registry will be: * entire information about the patients who admitted with COVID-19 accompany with a cardiovascular condition in Qatar. * Additionally, a comparison will be conducted between the cardiac patient who admitted over the period February to December to December 2020 and the same category of patients over the same period of 2019 in Qatar to figure out the reason behind the dropping of the number of the patient. * A multicenter data from the Gulf countries for Acute MI patients infected with COVID-19. * A comparison between our patients (either in Qatar only or the entire Gulf) populations and the outcome of other international registries such as the NACMI (US registry)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Dr.Jassim Alsuwaidi Senior Consultant principal investigator
HMC
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 Cardiovascular Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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 Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MRC (44396168, MRC@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of COVID-19 on cardiovascular patient (time frame: 2 month from starting date). 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 26 Jun 2020.