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NCT05875311 | RECRUITING | Chronic Coronary Syndrome


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

Catchronic hello sl

Brief Summary:

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.

Condition or disease

Chronic Coronary Syndrome

Intervention/treatment

telemonitoring

control follow-up

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : SINGLE
Masking Description : The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses and surveys will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.
Primary Purpose : PREVENTION
Official Title : Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
Actual Study Start Date : 2023-11-28
Estimated Primary Completion Date : 2024-09-01
Estimated Study Completion Date : 2024-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 72 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT05875311


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Locations


RECRUITING

Spain,

Arnau Hospital of Vilanova

Valencia, Spain, 46015

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