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Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)

Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)

Recruiting
18-72 years
All
Phase N/A

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Overview

In a randomized clinical trial, a comprehensive telerehabilitation system with a prolonged follow-up strategy demonstrated superiority over a control group with centre-based cardiac rehabilitation in terms of physical activity, VO2 max, adherence to a Mediterranean diet, lipid particle profile and cost-effectiveness. The aim of this study is to demonstrate an extension of the benefit to patients with chronic coronary syndrome in primary care.

Description

The patients who have suffered an acute coronary event have a recurrence rate of 2.5% to 15.5% person-years during the first year. Control of cardiovascular risk factors can improve the prognosis of these patients. Following the results of a clinical trial to validate a comprehensive monitoring system called Cardioplan, with a prolonged monitoring strategy, The investigators aim to conduct a study in patients with chronic coronary syndrome in the primary care setting comparing a control group with standard follow-up and a 10-month telemonitored group. Four primary care centres will participate. Two health centres attend mainly a population with a medium-high upper socioeconomic level and the other two mainly a population with a medium-low socioeconomic level. A total of 160 subjects are expected to be included in the follow-up, with 80 subjects in each study group. The primary endpoint is to demonstrate that telemonitored follow-up improves functional exercise capacity compared to usual care, by assessing the distance in meters covered in the 6-minute walk test.

Eligibility

Inclusion Criteria:

  • Signed informed consent
  • Patients after more than one year of an acute coronary syndrome of both sexes.
  • Age equal to or less than 72 years.

Exclusion Criteria:

  • Refusal of informed consent
  • Advanced biological age.
  • Kidney failure (GFR < 30ml/min/1.73 m2).
  • Liver failure (GOT >2 times normal value).
  • Ejection fraction less than 50%.
  • Uncontrolled blood pressure (>140/90 mmHg).
  • Uncontrolled heart failure.
  • Dissecting aortic aneurysm.
  • Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
  • Aortic or mitral valve disease.
  • Recent systemic or pulmonary embolism.
  • Active or recent thrombophlebitis.
  • Acute infectious diseases.
  • Uncontrolled supraventricular arrhythmias or tachycardia.
  • Repeated or frequent ventricular ectopic activity.
  • Moderate pulmonary hypertension.
  • Ventricular aneurysm.
  • Uncontrolled diabetes, thyrotoxicosis, myxedema,
  • Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
  • Wolf-Parkinson-White syndrome.
  • Fixed rate pacing.
  • Severe anaemia.
  • Psychoneurotic disorders.
  • Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.

Study details
    Chronic Coronary Syndrome

NCT05875311

Catcronic Salut SL

10 June 2024

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