Chronic Coronary Syndrome Clinical Trial
— TELSINCORCOfficial title:
Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | October 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 72 Years |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Arnau de Vilanova | Valencia |
Lead Sponsor | Collaborator |
---|---|
Catcronic Salut SL |
Spain,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The 6-min walk distance (6MWD) | Meters (m) | 10 months | |
Secondary | Maximal heart rate in the six minute walk test | beats per minute (bpm) | 10 months | |
Secondary | Total cholesterol | mg/dL | 10 months | |
Secondary | Glycosylated haemoglobin | Percentage (%) | 10 months | |
Secondary | Weight | Kilograms (Kg) | 10 months | |
Secondary | Waist circumference | waist circumference change (cm) | 10 months | |
Secondary | Visceral fat | percentage (%) | 10 months | |
Secondary | Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire | Kcal/week | 10 months | |
Secondary | High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire | percentage | 10 months | |
Secondary | Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED). | Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome. | 10 months | |
Secondary | Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome. | 10 months | |
Secondary | Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome. | 10 months | |
Secondary | Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome. | 10 months | |
Secondary | Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D) | Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome. | 10 months | |
Secondary | Health status obtained from the European Quality of Life questionnaire (EuroQol-5D) | Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome. | 10 months | |
Secondary | smoking cessation | percentage | 10 months | |
Secondary | User's experience from the System Usability Scale (SUS) score | Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome. | 10 months | |
Secondary | Cost-effectiveness analysis | net cost divided by changes in health outcomes | 10 months | |
Secondary | Body mass Index | weight and height will be combined to report BMI (kg/m^2) | 10 months | |
Secondary | High | centimeters (cm) | 10 months | |
Secondary | Percentage expected for age and sex in the six minute walk test | Percentage | 10 months | |
Secondary | Leukocyte count | WBCs per microliter | 10 month | |
Secondary | Neutrophil count | Neutrophils per microliter and percentage of white blood cells | 10 monts | |
Secondary | Lymphocyte count | Lymphocytes per microliter and percentage of white blood cells | 10 month | |
Secondary | Platelet count | Platelets per microliter | 10 month | |
Secondary | GlycA | µmol/L | 10 monts | |
Secondary | Small LDL particles | µmol/L | 10 months | |
Secondary | Physical activity derived from the International Physical Activity questionnaire (IPAQ) | self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome. | 10 months | |
Secondary | HDL cholesterol | mg/dL | 10 months | |
Secondary | LDL cholesterol | mg/dL | 10 months | |
Secondary | Non-HDL cholesterol | mg/dL | 10 months | |
Secondary | Triglycerides | mg/dL | 10 months | |
Secondary | Apolipoprotein B/Apolipoprotein A-I ratio | Units | 10 months |
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