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| Name | Class |
|---|---|
| Medical Sciences Academy - Romania | UNKNOWN |
| Victor Babes Clinical Hospital of Infectious Diseases - Bucharest | UNKNOWN |
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Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus.
Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found.
The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation).
The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.
Specific objective 1: Establishing the risk profile of the patient with cardiovascular disease
Specific objective 2: Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context
(Cardiology specialists, interventional cardiology, cardiovascular surgery, oncology, infectious diseases, diabetologists, family doctors, psychologists / psychiatrists, priests and religious advisors).
Deliverables for specific objectives:
Specific objective 3: Procedures regarding interventions on categories classified by cardiovascular emergencies
Activities for achieving the objective:
Specific objective 4: Campaign to promote the distance management method through specific e-Health methods to mitigate the psychological impact of using the distance diagnosis and treatment and implementing the procedures
The social pressure brought about by isolation of patients who would otherwise have benefited from frequent outpatient consultations for various problems, such as: adjusting doses of antihypertensive treatment, managing sporadic chest pain, managing body weight and diuresis in patients with heart failure, adjusting the schema, treatment based on heart rate and diuretic doses, chronic oral anticoagulant treatment or management of supraventricular tachyarrhythmias or extrasystolys at home.
In addition, isolation at home puts another kind of pressure (psychic in essence) on the patients who are also suffering from the mentioned chronic pathology. These patients bring the stress of isolation in relation to their own person, family / contacts, but also with the medical team in possible digital / wireless contact.
At this time, there are no management protocols for patients with such a degree of complexity, the telemetry problem being only isolated, as far as local resources and specific objectives are concerned, in no case viewed in their entirety.
The major problem that arises with the isolation of these patients is that they cannot be admitted to hospitals for problems of low severity compared to the current territorial capacities, and at the same time, they cannot be left unattended - by abolishing / blocking the medical activity in the specialized outpatient clinics. .
It cannot be said that there is similar experience with the current epidemiological situation and there are no Guides or directions of institutionalized medical practice.
This particular situation more likely makes experts to witness an increase in the complications of cardiovascular diseases through the lack of direct management (heart failure compensations), early and long-term complications of tension jumps or uncontrolled tension values, and possibly acute coronary syndromes).
Moreover, the coronary patients who are instrumented by stenting, see the impossibility to come to the periodic checks at 1 month, 3 months, 6 months, 9 months and one year after the coronary stenting, as there is no alternative solution to the closure of the outpatients.
Specific objective 5: Evaluation of the social, environmental and economic impact determined by the proposed management system
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients with known cardiovascular disease | Experimental | All these patients will be provided an electronic account on a dedicated platform were they can be supervised and can call for advice / help. This kind of tele-medical project aims to keep these patients in a so-called proximity, monitoring their vital parameters, checking their medication and providing dedicated advices according to their complaints. Moreover, all these patients will receive digital watches with ecg-recording capabilities, thus a dedicated physician could correlate their symptoms with few clear paraclinical variables. All of these patients' complaints will be stratified according to elaborated protocols based on the European Cardiovascular Guidelines. Moreover, a psychologist and a chaplain will deal with their (new) problems due to social isolation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-medicine platform | Other | Electronic counselling of known pathology cardiovascular patients through a complex remote platform and dedicated experts. This project intend remote monitoring through wearable devices (e.g. ECG watches, pulse detectors, oximetry). |
| Measure | Description | Time Frame |
|---|---|---|
| Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients | Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context | 6 months |
| Number of patients included in this platform | patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication); | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of consultations/sessions given | Will be the number of sessions per patient multiplied with the number of patients included | 6 months |
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Inclusion Criteria:
all known cardiovascular patients from local Cardiology Clinics, with:
AND isolated / quarantined recommendations (due to COVID 19 pandemic).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandru Burlacu, MD, PhD | Contact | 0040744488580 | alexandru.burlacu@umfiasi.ro |
| Name | Affiliation | Role |
|---|---|---|
| Alexandru Burlacu, MD, PhD | University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania | Principal Investigator |
| Cristina Plesoianu, PhD | Medical Sciences Academy from Romania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Sciences Academy | Recruiting | Bucharest | Romania |
If this platform will be functional, we are willing to provide the system and protocols and know-how to other centers in Romania.
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All patients with severe cardiovascular disease benefit from this project
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| University of Medicine and Pharmacy Gr T Popa | Recruiting | Iași | 700503 | Romania |
|
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D054058 | Acute Coronary Syndrome |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| D006973 | Hypertension |
| D054143 | Heart Failure, Systolic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000086382 | COVID-19 |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006333 | Heart Failure |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012919 | Social Behavior |
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