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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Hamad Medical Corporation

    Doha, Unlisted (UL), 974

    DR.Jassim Alsuwaidi Senior Consultant, 44395392, jalsuwaidi@hamad.qa

    Recruiting

Other trials in Qatar

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.

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.

  1. 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.

  1. First posted12 Jun 2020
  2. Study start2 Jun 2020
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

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
Other
Enrolment
100 participants (estimated)
Target duration
1 Week
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

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.

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