Telemedicine Follow-up for Post-ACS Patients

Study Overview
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Brief Summary
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The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients

Detailed Description
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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.

Official Title
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Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients

Conditions
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ACS - Acute Coronary Syndrome

Intervention / Treatment
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* Other: Telemedicine FU
* Other: Office FU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine follow-up visit, Post-ACS rehabilitation