Telemedicine Follow-up for Post-ACS Patients

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

Study Overview

• Status: Completed
• Conditions: ACS - Acute Coronary Syndrome
• Intervention / Treatment: Other: Telemedicine FU; Other: Office FU

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tyumen, Russian Federation, 625026
    • Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine FU; Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.	Other: Telemedicine FU; Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Active Comparator: Office FU; Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.	Other: Office FU; Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	1 year
LDL < 1.4 mmol/L	Low density lipoprotein< 1.4 mmol/L	1 year
Not smoking	Not smoking	1 year
Decrease in overweight	Decrease in overweight	1 year
Aspirin or other antiplatelet or anticoagulant	Adherence to aspirin or other antiplatelet or anticoagulant	1 year
Adherence to prescribed medication	Adherence to prescribed at discharge medication	1 year
Hospitalization	Hospitalization for cardiac reasons	1 year

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Ivan S Bessonov, MD, PhD, Tyumen Cardiology Research Center

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine follow-up visit; Post-ACS rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: TeleFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No