Telemedicine Follow-up for Post-ACS Patients

ACS - Acute Coronary Syndrome Clinical Trial

Official title:

Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485754
• Other study ID #: TeleFU
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• Syndrome

Intervention

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.
• Office FU
Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Locations

Country	Name	City	State
Russian Federation	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke	1 year
Secondary	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
Secondary	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
Secondary	LDL < 1.4 mmol/L	Low density lipoprotein< 1.4 mmol/L	1 year
Secondary	Not smoking	Not smoking	1 year
Secondary	Decrease in overweight	Decrease in overweight	1 year
Secondary	Aspirin or other antiplatelet or anticoagulant	Adherence to aspirin or other antiplatelet or anticoagulant	1 year
Secondary	Adherence to prescribed medication	Adherence to prescribed at discharge medication	1 year
Secondary	Hospitalization	Hospitalization for cardiac reasons	1 year