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RecruitingNCT05875311TELSINCORCUpdated Jun 4, 2024

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

An interventional study of telemonitoring and control follow-up in Chronic Coronary Syndrome, sponsored by Catcronic Salut SL. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Catcronic Salut SL · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Coronary Syndrome

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Keywords

  • mobile health
  • Chronic coronary syndrome
  • cardiac rehabilitation
  • telerehabilitation
  • secondary prevention
  • exercise
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 160 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Catcronic Salut SL is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    telemonitoring

    Patients in the intervention group will come to the ambulatory centre 2 times, undergoing mobile application training and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.

    Device: telemonitoring

  • Other
    control follow-up

    Patients in the control group will come to the ambulatory centre only once. The same educational talks as to the intervention group will be given. A conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.

    Other: control follow-up

Interventions

  • Devicetelemonitoring

    The system consists of the following elements: Professional website at the ambulatory centre, which allows: To set up an individualised care plan To establish the patient's risk profile and targets for improvement. Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred Advise the patient on self-management strategies. Mobile application software with the following functions: Scheduled exercise sessions Medication reminder Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.) Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference. Training monitor: guides the patient in the performance of their exercise. Access to certified health information for patients

  • Othercontrol follow-up

    Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

06

What researchers measure

Primary outcomes

  1. The 6-min walk distance (6MWD)

    Meters (m)

    Time frame: 10 months

Secondary outcomes

  1. Maximal heart rate in the six minute walk test

    beats per minute (bpm)

    Time frame: 10 months

  2. Total cholesterol

    mg/dL

    Time frame: 10 months

  3. Glycosylated haemoglobin

    Percentage (%)

    Time frame: 10 months

  4. Weight

    Kilograms (Kg)

    Time frame: 10 months

  5. Waist circumference

    waist circumference change (cm)

    Time frame: 10 months

  6. Visceral fat

    percentage (%)

    Time frame: 10 months

  7. Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    Kcal/week

    Time frame: 10 months

  8. High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    percentage

    Time frame: 10 months

  9. 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.

    Time frame: 10 months

  10. 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.

    Time frame: 10 months

  11. 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.

    Time frame: 10 months

  12. 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.

    Time frame: 10 months

  13. 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.

    Time frame: 10 months

  14. 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.

    Time frame: 10 months

  15. smoking cessation

    percentage

    Time frame: 10 months

  16. User's experience from the System Usability Scale (SUS) score

    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.

    Time frame: 10 months

  17. Cost-effectiveness analysis

    net cost divided by changes in health outcomes

    Time frame: 10 months

  18. Body mass Index

    weight and height will be combined to report BMI (kg/m\^2)

    Time frame: 10 months

  19. High

    centimeters (cm)

    Time frame: 10 months

  20. Percentage expected for age and sex in the six minute walk test

    Percentage

    Time frame: 10 months

  21. Leukocyte count

    WBCs per microliter

    Time frame: 10 month

  22. Neutrophil count

    Neutrophils per microliter and percentage of white blood cells

    Time frame: 10 monts

  23. Lymphocyte count

    Lymphocytes per microliter and percentage of white blood cells

    Time frame: 10 month

  24. Platelet count

    Platelets per microliter

    Time frame: 10 month

  25. GlycA

    μmol/L

    Time frame: 10 monts

  26. Small LDL particles

    μmol/L

    Time frame: 10 months

  27. 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.

    Time frame: 10 months

  28. HDL cholesterol

    mg/dL

    Time frame: 10 months

  29. LDL cholesterol

    mg/dL

    Time frame: 10 months

  30. Non-HDL cholesterol

    mg/dL

    Time frame: 10 months

  31. Triglycerides

    mg/dL

    Time frame: 10 months

  32. Apolipoprotein B/Apolipoprotein A-I ratio

    Units

    Time frame: 10 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Arnau de Vilanova
    Valencia, 46015, Spain
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35944773 ↗
  • 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. PubMed 34952989 ↗
  • 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. PubMed 29966801 ↗
  • 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. PubMed 34788451 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875311
Lead sponsor
Catcronic Salut SL
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Nov 28, 2023
Primary completion
Sep 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Jun 4, 2024

Study contacts

Ernesto Dalli Peydró, MD
Contact
ernestodallip@gmail.com
+34626388083
Juan Cosín-Sales, MD
Contact
cosin_jua@gva.es
+34606338503
Ernesto Dalli Peydró, MD
principal investigator · Hospital Arnau de VIlanova. Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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