Telemedicine Follow-up for Post-ACS Patients

Not Applicable

Completed

• Conditions: ACS - Acute Coronary Syndrome
• Interventions: Other: Telemedicine FU; Other: Office FU

• Registration Number: NCT04485754
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine FU	Telemedicine FU	Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Office FU	Office FU	Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Primary Outcome Measures

Name	Time	Method
MACCE	1 year	Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke

Secondary Outcome Measures

Name	Time	Method
Decrease in overweight	1 year	Decrease in overweight
Adherence to prescribed medication	1 year	Adherence to prescribed at discharge medication
Hospitalization	1 year	Hospitalization for cardiac reasons
PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)	1 year	Blood pressure \< 140 mm/Hg (\<135/85 mm/Hg for for patients with diabetes mellitus)
LDL < 1.4 mmol/L	1 year	Low density lipoprotein\< 1.4 mmol/L
Not smoking	1 year	Not smoking
Aspirin or other antiplatelet or anticoagulant	1 year	Adherence to aspirin or other antiplatelet or anticoagulant
High level of MT optimization	1 year	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.

Trial Locations

Locations (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science; 🇷🇺 Tyumen, Russian Federation