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Telemedicine Follow-up for Post-ACS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485754
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
ACS - Acute Coronary Syndrome Other: Telemedicine FU Other: Office FU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Telemedicine FU
Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
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.

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




Primary Outcome Measures :
  1. MACCE [ Time Frame: 1 year ]
    Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke


Secondary Outcome Measures :
  1. High level of MT optimization [ Time Frame: 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.

  2. PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes) [ Time Frame: 1 year ]
    Blood pressure < 140 mm/Hg (<135/85 mm/Hg for for patients with diabetes mellitus)

  3. LDL < 1.4 mmol/L [ Time Frame: 1 year ]
    Low density lipoprotein< 1.4 mmol/L

  4. Not smoking [ Time Frame: 1 year ]
    Not smoking

  5. Decrease in overweight [ Time Frame: 1 year ]
    Decrease in overweight

  6. Aspirin or other antiplatelet or anticoagulant [ Time Frame: 1 year ]
    Adherence to aspirin or other antiplatelet or anticoagulant

  7. Adherence to prescribed medication [ Time Frame: 1 year ]
    Adherence to prescribed at discharge medication

  8. Hospitalization [ Time Frame: 1 year ]
    Hospitalization for cardiac reasons



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485754


Contacts
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Contact: Ivan S Bessonov, MD, PhD +79068237755 ivanbessnv@gmail.com
Contact: Stanislav S Sapozhnikov, MD +79091919191 stas_ss@bk.ru

Locations
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Russian Federation
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science Recruiting
Tyumen, Russian Federation, 625026
Contact: Ivan S Bessonov    +79068237755    ivanbessnv@gmail.com   
Contact: Stanislav S Sapozhnikov    +79091919191    stas_ss@bk.ru   
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Principal Investigator: Ivan S Bessonov, MD, PhD Tyumen Cardiology Research Center
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT04485754    
Other Study ID Numbers: TeleFU
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
Telemedicine follow-up visit
Post-ACS rehabilitation
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases