Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Coronary Syndrome
  • Angina Pectoris
  • Angioplasty
  • Coronary (Artery) Disease
  • Coronary Syndrome
  • COVID-19
  • Depression, Anxiety
  • Heart Failure Systolic
  • Hypertension
  • Isolation, Social
  • Stent Restenosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All patients with severe cardiovascular disease benefit from this projectMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

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, in...

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). the patient is included in the AngioNET research database and automatically creates an account on the M platform and gives the consent for the data transfer on the platform or the patient registers directly on the M platform and uploads his medical data (analysis and imaging) to his personal account; patients complete the section with data specific to the coronavirus pandemic; the patients select the type of consultation they request and they are redirected to specific sections with dedicated multidisciplinary teams; 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); the classification of patients in emergency categories and the follow-up of specific trajectories: 1 - 911 for transporting patients to the hospital in an emergency (for cardiovascular emergencies or COVID symptoms); 2 - adjusted drug therapy, followed by accelerated monitoring for periodic evaluations in order to decide to pass in category 1 or 3; 3 - establishing drug treatment and monitoring. Over all these categories, specific protection measures in the case of coronavirus infection overlap monitoring the short and medium term evolution of patients in isolation (vital parameters, transmitted through the provided wireless devices) Detailed / and largely based protocols will be developed based on the recommendations of the Guidelines, but also on the experts' opinion and on the local expertise (pandemic, national emergency) for at least three categories. Deliverables for specific objectives: functional management platform for patients with cardiovascular disease, bodily and intangible assets necessary for the functioning of the platform; multidisciplinary teams with the reaction speed adapted to the specific of each case / emergency category; emergency counseling schemes, including psychological and religious counseling; collection, interpretation and processing conclusions given in management optimization policies for patients with cardiovascular diseases. Specific objective 3: Procedures regarding interventions on categories classified by cardiovascular emergencies Activities for achieving the objective: elaboration of procedures on categories of emergencies in the presence of coronavirus: 1- urgent interventional / surgical / hybrid therapy; 2- short-term drug treatment for the subsequent therapeutic intervention; 3 - drug treatment for cardiovascular pathology doubled by coronavirus treatment follow-up for obtaining medical data, including epidemiological and related to the environmental parameters at the place where the patient belongs and their processing for the purpose of optimizing public health measures in patients with cardiovascular diseases 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 impact study: social (physical and mental health, religion contributions and technological development in the studied patient profile structure, interaction with public and private health and social institutions) and quantifying the influence of atmospheric pollution factors on the studied patients, risk maps depending on patient location; cost management model for the targeted patients, quantification of upstream and downstream costs reduction, general impact on the costs in the health system, the social system as well as the budget allocated from own sources by the patients / patients involved.

Tracking Information

NCT #
NCT04325867
Collaborators
  • Medical Sciences Academy - Romania
  • Victor Babes Clinical Hospital of Infectious Diseases - Bucharest
Investigators
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