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

Not Applicable

Recruiting

• Conditions: Chronic Coronary Syndrome

• Registration Number: NCT05875311
• Lead Sponsor: Catcronic Salut 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.

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 Timeline

• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-25
• Study Start: 2023-11-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The 6-min walk distance (6MWD)	10 months	Meters (m)

Secondary Outcome Measures

Name	Time	Method
LDL cholesterol	10 months	mg/dL
Non-HDL cholesterol	10 months	mg/dL
Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)	10 months	Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)	10 months	Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
GlycA	10 monts	μmol/L
Glycosylated haemoglobin	10 months	Percentage (%)
Weight	10 months	Kilograms (Kg)
smoking cessation	10 months	percentage
Physical activity derived from the International Physical Activity questionnaire (IPAQ)	10 months	self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
Triglycerides	10 months	mg/dL
Total cholesterol	10 months	mg/dL
Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire	10 months	Kcal/week
Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)	10 months	Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Body mass Index	10 months	weight and height will be combined to report BMI (kg/m\^2)
Maximal heart rate in the six minute walk test	10 months	beats per minute (bpm)
Visceral fat	10 months	percentage (%)
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire	10 months	percentage
Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)	10 months	Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)	10 months	Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
Cost-effectiveness analysis	10 months	net cost divided by changes in health outcomes
High	10 months	centimeters (cm)
Percentage expected for age and sex in the six minute walk test	10 months	Percentage
Neutrophil count	10 monts	Neutrophils per microliter and percentage of white blood cells
Lymphocyte count	10 month	Lymphocytes per microliter and percentage of white blood cells
Small LDL particles	10 months	μmol/L
HDL cholesterol	10 months	mg/dL
Apolipoprotein B/Apolipoprotein A-I ratio	10 months	Units
Waist circumference	10 months	waist circumference change (cm)
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).	10 months	Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
User's experience from the System Usability Scale (SUS) score	10 months	Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Leukocyte count	10 month	WBCs per microliter
Platelet count	10 month	Platelets per microliter

Trial Locations

Locations (1)

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain