Angina PectoriseCardioCovid19NCT04325867
Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19
A study testing Tele-medicine platform in people with Angina Pectoris and Acute Coronary Syndrome, run by Professor Adrian Covic at 2 sites in Romania.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Acute Coronary Syndrome, Coronary Syndrome
- What is being tested?
- Tele-medicine platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesRomania
- Study dates
- 31 Mar 2020to 1 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- all known cardiovascular patients from local Cardiology Clinics, with:
- all spectrum of coronary syndromes (chronic to acute) +/- known coronary angioplasties;
- treated arterial hypertension;
- known congestive heart failure
- AND isolated / quarantined recommendations (due to COVID 19 pandemic).
Who cannot join
- refusal / denial to create an electronic account on this dedicated platform;
- refusal to accept wearable devices (ecg watches, oximetry).
Trial locations and contacts
2 sites in 1 country.
Romania2 sites, 2 recruiting
- Recruiting
Medical Sciences Academy
Bucharest
Cristina Plesoianu, PhD, 0040722270066, cristina.plesoianu@angionet.ro
- Recruiting
University of Medicine and Pharmacy Gr T Popa
Iași, 700503
Alexandru Burlacu, MD, PhD, 0040744488580, alexandru.burlacu@umfiasi.ro
About this study
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
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.
Read more
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.
Read the detailed 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, 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.
- Conditions
- Angina Pectoris, Acute Coronary Syndrome, Coronary Syndrome, Coronary Artery Disease, Angioplasty, Stent Restenosis
- Being tested
- Tele-medicine platform
- Keywords
- e-Health, Tele-Medicine, Remote medical surveillance, psychological counseling
- Medical subject headings
- Angina Pectoris, Acute Coronary Syndrome, Angina, Unstable, Coronary Artery Disease, Hypertension, Heart Failure, Systolic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-medicine platformOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tele-medicine platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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);
Measured: 6 months
Secondary outcomes (1)
Number of consultations/sessions given
Will be the number of sessions per patient multiplied with the number of patients included
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start31 Mar 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with severe cardiovascular disease benefit from this project
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Adrian Covic
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Sciences Academy - Romania, Victor Babes Clinical Hospital of Infectious Diseases - Bucharest
- Responsible party
- Sponsor-investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Alexandru Burlacu, MD, PhD, Principal investigator, University of Medicine and Pharmacy "Gr. T. Popa" Iasi, RomaniaCristina Plesoianu, PhD, Study director, Medical Sciences Academy from Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325867
- Sponsor's protocol ID
- GTP0032
- Acronym
- eCardioCovid19
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If this platform will be functional, we are willing to provide the system and protocols and know-how to other centers in Romania.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04325867
- Acronym / sponsor ID
- eCardioCovid19 / GTP0032
- Conditions
- Angina Pectoris, Acute Coronary Syndrome, Coronary Syndrome, Coronary Artery Disease, Angioplasty, Stent Restenosis
- Keywords
- e-Health, Tele-Medicine, Remote medical surveillance, psychological counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Professor Adrian CovicUniversity, hospital or other
- Collaborators
- Medical Sciences Academy - Romania, Victor Babes Clinical Hospital of Infectious Diseases - Bucharest
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 30 Mar 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.
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.
Detailed 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, 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with severe cardiovascular disease benefit from this project
| Arm | Type | Receives |
|---|---|---|
| All patients with known cardiovascular disease | Experimental | Other: Tele-medicine platformAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- all known cardiovascular patients from local Cardiology Clinics, with:
- AND isolated / quarantined recommendations (due to COVID 19 pandemic).
Key exclusion criteria (2 listed)
- refusal / denial to create an electronic account on this dedicated platform;
- refusal to accept wearable devices (ecg watches, oximetry).
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 |
|---|---|---|
| Tele-medicine platformElectronic 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). | Other | All patients with known cardiovascular disease |
Primary outcome
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
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);
1 secondary outcome
Number of consultations/sessions given
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Yes. If this platform will be functional, we are willing to provide the system and protocols and know-how to other centers in Romania.
Related trials for Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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.
Alexandru Burlacu, MD, PhD principal investigator
University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
Cristina Plesoianu, PhD study director
Medical Sciences Academy from Romania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-medicine platform in people with Angina Pectoris and Acute Coronary Syndrome, run by Professor Adrian Covic at 2 sites in Romania.
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 5 inclusion and 2 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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 Alexandru Burlacu, MD, PhD (0040744488580, alexandru.burlacu@umfiasi.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 Apr 2020.