NCT04485754

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

July 21, 2020

Last Update Submit

June 23, 2026

Conditions

ACS - Acute Coronary Syndrome

Keywords

Telemedicine follow-up visitPost-ACS rehabilitation

Outcome Measures

Primary Outcomes (1)

  • MACCE

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

    1 year

Secondary Outcomes (8)

  • High level of MT optimization

    1 year

  • PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)

    1 year

  • LDL < 1.4 mmol/L

    1 year

  • Not smoking

    1 year

  • Decrease in overweight

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Telemedicine FU

EXPERIMENTAL

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

Other: Telemedicine FU

Office FU

ACTIVE COMPARATOR

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

Other: Office FU

Interventions

Telemedicine FUOTHER

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

Telemedicine FU
Office FUOTHER

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

Office FU

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age ≥ 40 years
  • PCI with coronary artery stenting for ACS
  • Angiographic success PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tyumen, 625026, Russia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ivan S Bessonov, MD, PhD

    Tyumen Cardiology Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

May 15, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)