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Telemedicine Follow-up for Post-ACS Patients

Primary Purpose

ACS - Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Telemedicine FU
Office FU
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ACS - Acute Coronary Syndrome focused on measuring Telemedicine follow-up visit, Post-ACS rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent
  2. Age ≥ 40 years
  3. PCI with coronary artery stenting for ACS
  4. Angiographic success PCI

Exclusion Criteria:

  1. Patients with cancer
  2. Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA)
  3. Severe valvular heart disease or Prosthetic heart valves.
  4. Severe forms of CKD (GFR<30mL/min)
  5. Planned staged revascularization during the next 12 months
  6. Planned surgery within the next 12 months

Sites / Locations

  • Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine FU

Office FU

Arm Description

Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Outcomes

Primary Outcome Measures

MACCE
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke

Secondary Outcome Measures

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.
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)
LDL < 1.4 mmol/L
Low density lipoprotein< 1.4 mmol/L
Not smoking
Not smoking
Decrease in overweight
Decrease in overweight
Aspirin or other antiplatelet or anticoagulant
Adherence to aspirin or other antiplatelet or anticoagulant
Adherence to prescribed medication
Adherence to prescribed at discharge medication
Hospitalization
Hospitalization for cardiac reasons

Full Information

First Posted
July 21, 2020
Last Updated
April 26, 2022
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04485754
Brief Title
Telemedicine Follow-up for Post-ACS Patients
Official Title
Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACS - Acute Coronary Syndrome
Keywords
Telemedicine follow-up visit, Post-ACS rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine FU
Arm Type
Experimental
Arm Description
Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Arm Title
Office FU
Arm Type
Active Comparator
Arm Description
Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Intervention Type
Other
Intervention Name(s)
Telemedicine FU
Intervention Description
Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Intervention Type
Other
Intervention Name(s)
Office FU
Intervention Description
Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Primary Outcome Measure Information:
Title
MACCE
Description
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
High level of MT optimization
Description
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.
Time Frame
1 year
Title
PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)
Description
Blood pressure < 140 mm/Hg (<135/85 mm/Hg for for patients with diabetes mellitus)
Time Frame
1 year
Title
LDL < 1.4 mmol/L
Description
Low density lipoprotein< 1.4 mmol/L
Time Frame
1 year
Title
Not smoking
Description
Not smoking
Time Frame
1 year
Title
Decrease in overweight
Description
Decrease in overweight
Time Frame
1 year
Title
Aspirin or other antiplatelet or anticoagulant
Description
Adherence to aspirin or other antiplatelet or anticoagulant
Time Frame
1 year
Title
Adherence to prescribed medication
Description
Adherence to prescribed at discharge medication
Time Frame
1 year
Title
Hospitalization
Description
Hospitalization for cardiac reasons
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age ≥ 40 years PCI with coronary artery stenting for ACS Angiographic success PCI Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan S Bessonov, MD, PhD
Organizational Affiliation
Tyumen Cardiology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telemedicine Follow-up for Post-ACS Patients

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