ACS - Acute Coronary SyndromeNCT04485754
Telemedicine Follow-up for Post-ACS Patients
A study testing Telemedicine FU and Office FU in people with ACS - Acute Coronary Syndrome, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- ACS - Acute Coronary Syndrome
- What is being tested?
- Telemedicine FU and Office FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2020to 31 Dec 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age ≥ 40 years
- PCI with coronary artery stenting for ACS
- Angiographic success PCI
Who cannot join
- Patients with cancer
- Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA)
- Severe valvular heart disease or Prosthetic heart valves.
- Severe forms of CKD (GFR<30mL/min)
- Planned staged revascularization during the next 12 months
- Planned surgery within the next 12 months
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, 625026
About this study
Official title: Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients
The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients
Read the detailed description
Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.
- Conditions
- ACS - Acute Coronary Syndrome
- Being tested
- Telemedicine FU, Office FU
- Keywords
- Telemedicine follow-up visit, Post-ACS rehabilitation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine FUOther
Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Office FUOther
Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine FU | Experimental | Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. Receives: Other: Telemedicine FU |
| Office FU | Active comparator | Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. Receives: Other: Office FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke
Measured: 1 year
Secondary outcomes (8)
High level of MT optimization
High Level of Medical Therapy Optimization is defined as a participant meeting all of the following goals: LDL < 1.4 mmol/L and on any statin, blood pressure < 140/90 mm/Hg (<135/85 mm/Hg for patients with diabetes mellitus), on aspirin or other antiplatelet or anticoagulant, and not smoking. High level of medical therapy optimization is missing if any of the individual goals are missing.
Measured: 1 year
PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)
Blood pressure < 140 mm/Hg (<135/85 mm/Hg for for patients with diabetes mellitus)
Measured: 1 year
LDL < 1.4 mmol/L
Low density lipoprotein< 1.4 mmol/L
Measured: 1 year
Not smoking
Not smoking
Measured: 1 year
Decrease in overweight
Decrease in overweight
Measured: 1 year
Aspirin or other antiplatelet or anticoagulant
Adherence to aspirin or other antiplatelet or anticoagulant
Measured: 1 year
Adherence to prescribed medication
Adherence to prescribed at discharge medication
Measured: 1 year
Hospitalization
Hospitalization for cardiac reasons
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 May 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS - Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan S Bessonov, MD, PhD, Principal investigator, Tyumen Cardiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485754
- Sponsor's protocol ID
- TCRC-158
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT04485754
- Acronym / sponsor ID
- TCRC-158
- Conditions
- ACS - Acute Coronary Syndrome
- Keywords
- Telemedicine follow-up visit, Post-ACS rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jul 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.
The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients
Detailed description
Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine FU | Experimental | Other: Telemedicine FUTelemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. |
| Office FU | Active comparator | Other: Office FUOffice follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Age ≥ 40 years
- PCI with coronary artery stenting for ACS
- Angiographic success PCI
Key exclusion criteria (6 listed)
- Patients with cancer
- Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA)
- Severe valvular heart disease or Prosthetic heart valves.
- Severe forms of CKD (GFR<30mL/min)
- Planned staged revascularization during the next 12 months
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 |
|---|---|---|
| Telemedicine FUParticipant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. | Other | Telemedicine FU |
| Office FUParticipant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital. | Other | Office FU |
Primary outcome
MACCE
Time frame: 1 year
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke
8 secondary outcomes
High level of MT optimization
Time frame: 1 year
PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)
Time frame: 1 year
LDL < 1.4 mmol/L
Time frame: 1 year
Not smoking
Time frame: 1 year
Decrease in overweight
Time frame: 1 year
Aspirin or other antiplatelet or anticoagulant
Time frame: 1 year
Adherence to prescribed medication
Time frame: 1 year
Hospitalization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ivan S Bessonov, MD, PhD principal investigator
Tyumen Cardiology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine FU and Office FU in people with ACS - Acute Coronary Syndrome, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jun 2026. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 1 year). 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 24 Jun 2026.