Telemedicine Follow-up for Post-ACS Patients

NCT ID: NCT04485754

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-12-31

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.

Conditions

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ACS - Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Telemedicine FU

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

Group Type EXPERIMENTAL

Telemedicine FU

Intervention Type OTHER

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

Office FU

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

Group Type ACTIVE_COMPARATOR

Office FU

Intervention Type OTHER

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

Interventions

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Telemedicine FU

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan S Bessonov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tyumen Cardiology Research Center

Locations

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

Tyumen, , Russia

Site Status

Countries

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Russia

Other Identifiers

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TeleFU

Identifier Type: -

Identifier Source: org_study_id

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