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Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19 (eCardioCovid19)

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ClinicalTrials.gov Identifier: NCT04325867
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
Medical Sciences Academy - Romania
Victor Babes Clinical Hospital of Infectious Diseases - Bucharest
Information provided by (Responsible Party):
Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Angina Pectoris Acute Coronary Syndrome Coronary Syndrome Coronary Artery Disease Angioplasty Stent Restenosis Hypertension Heart Failure, Systolic Depression, Anxiety Covid-19 Isolation, Social Other: Tele-medicine platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients with severe cardiovascular disease benefit from this project
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrated Distance Management Strategy for Patients With Cardiovascular Disease (Ischaemic Coronary Artery Disease, High Blood Pressure, Heart Failure) in the Context of the COVID-19 Pandemic
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients with known cardiovascular disease

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.

Other: Tele-medicine platform
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).




Primary Outcome Measures :
  1. Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients [ Time Frame: 6 months ]
    Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context

  2. Number of patients included in this platform [ Time Frame: 6 months ]
    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);


Secondary Outcome Measures :
  1. Number of consultations/sessions given [ Time Frame: 6 months ]
    Will be the number of sessions per patient multiplied with the number of patients included



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all known cardiovascular patients from local Cardiology Clinics, with:

    1. all spectrum of coronary syndromes (chronic to acute) +/- known coronary angioplasties;
    2. treated arterial hypertension;
    3. known congestive heart failure
  • AND isolated / quarantined recommendations (due to COVID 19 pandemic).

Exclusion Criteria:

  • refusal / denial to create an electronic account on this dedicated platform;
  • refusal to accept wearable devices (ecg watches, oximetry).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325867


Contacts
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Contact: Alexandru Burlacu, MD, PhD 0040744488580 alexandru.burlacu@umfiasi.ro

Locations
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Romania
Medical Sciences Academy Recruiting
Bucharest, Romania
Contact: Cristina Plesoianu, PhD    0040722270066    cristina.plesoianu@angionet.ro   
University of Medicine and Pharmacy Gr T Popa Recruiting
Iasi, Romania, 700503
Contact: Alexandru Burlacu, MD, PhD    0040744488580    alexandru.burlacu@umfiasi.ro   
Sponsors and Collaborators
Professor Adrian Covic
Medical Sciences Academy - Romania
Victor Babes Clinical Hospital of Infectious Diseases - Bucharest
Investigators
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Principal Investigator: Alexandru Burlacu, MD, PhD University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
Study Director: Cristina Plesoianu, PhD Medical Sciences Academy from Romania
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Responsible Party: Professor Adrian Covic, Professor, Vice-rector, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT04325867    
Other Study ID Numbers: GTP0032
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If this platform will be functional, we are willing to provide the system and protocols and know-how to other centers in Romania.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy:
e-Health
Tele-Medicine
Remote medical surveillance
psychological counseling
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina Pectoris
Heart Failure, Systolic
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations