Clinical trial NCT05875311: Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)
Official title: Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Coronary Syndrome
Keywords: mobile health
Chronic coronary syndrome
cardiac rehabilitation
telerehabilitation
secondary prevention
exercise
Lead sponsor: Catcronic Salut SL
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, open-label, prospective, parallel-group study
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The 6-min walk distance (6MWD)
timeFrame: 10 months
Secondary outcomes:
measure: Maximal heart rate in the six minute walk test
timeFrame: 10 months
measure: Total cholesterol
timeFrame: 10 months
measure: Glycosylated haemoglobin
timeFrame: 10 months
measure: Weight
timeFrame: 10 months
measure: Waist circumference
timeFrame: 10 months
measure: Visceral fat
timeFrame: 10 months
measure: Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
timeFrame: 10 months
measure: High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
timeFrame: 10 months
measure: Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
timeFrame: 10 months
measure: Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
timeFrame: 10 months
measure: Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
timeFrame: 10 months
measure: smoking cessation
timeFrame: 10 months
measure: User's experience from the System Usability Scale (SUS) score
timeFrame: 10 months
measure: Cost-effectiveness analysis
timeFrame: 10 months
measure: Body mass Index
timeFrame: 10 months
measure: High
timeFrame: 10 months
measure: Percentage expected for age and sex in the six minute walk test
timeFrame: 10 months
measure: Leukocyte count
timeFrame: 10 month
measure: Neutrophil count
timeFrame: 10 monts
measure: Lymphocyte count
timeFrame: 10 month
measure: Platelet count
timeFrame: 10 month
measure: GlycA
timeFrame: 10 monts
measure: Small LDL particles
timeFrame: 10 months
measure: Physical activity derived from the International Physical Activity questionnaire (IPAQ)
timeFrame: 10 months
measure: HDL cholesterol
timeFrame: 10 months
measure: LDL cholesterol
timeFrame: 10 months
measure: Non-HDL cholesterol
timeFrame: 10 months
measure: Triglycerides
timeFrame: 10 months
measure: Apolipoprotein B/Apolipoprotein A-I ratio
timeFrame: 10 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hospital Arnau de VIlanova. Valencia
name: Ernesto Dalli Peydró, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalli-Peydro E, Gisbert-Criado R, Amigo N, Sanz-Sevilla N, Cosin-Sales J. Cardiac telerehabilitation with long-term follow-up reduces GlycA and improves lipoprotein particle profile: A randomised controlled trial. Int J Cardiol. 2022 Dec 15;369:60-64. doi: 10.1016/j.ijcard.2022.08.017. Epub 2022 Aug 6.
citation: Dalli Peydro E, Sanz Sevilla N, Tuzon Segarra MT, Miro Palau V, Sanchez Torrijos J, Cosin Sales J. A randomized controlled clinical trial of cardiac telerehabilitation with a prolonged mobile care monitoring strategy after an acute coronary syndrome. Clin Cardiol. 2022 Jan;45(1):31-41. doi: 10.1002/clc.23757. Epub 2021 Dec 24.
citation: Paoli G, Notarangelo MF, Mattioli M, La Sala R, Foa C, Solinas E, Fusco S, Fava C, Caminiti C, Artioli G, Pela G, Dall'Aglio E, Manari A, Tondi S, Rizzo A, Trapolin G, Patrizi G, Cappelli S, Villani GQ, Piepoli M, Zobbi G, Nicosia E, Ardissino D. ALLiance for sEcondary PREvention after an acute coronary syndrome. The ALLEPRE trial: A multicenter fully nurse-coordinated intensive intervention program. Am Heart J. 2018 Sep;203:12-16. doi: 10.1016/j.ahj.2018.06.001. Epub 2018 Jun 12.
citation: Buckley BJR, de Koning IA, Harrison SL, Fazio-Eynullayeva E, Underhill P, Kemps HMC, Lip GYH, Thijssen DHJ. Exercise-based cardiac rehabilitation vs. percutaneous coronary intervention for chronic coronary syndrome: impact on morbidity and mortality. Eur J Prev Cardiol. 2022 May 25;29(7):1074-1080. doi: 10.1093/eurjpc/zwab191.