NCT05351775Befejeződött
Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Cardiovascular Research Consortium - a Randomized Prospective Trial to Assess Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 30.
Rövid összefoglaló (regiszter, angolul)
Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. CARE-DETECT algorithm development part I will investigate following topics: 1. The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG) 2. Accuracy of AF detection from PDL data 3. Technical development of algorithms to detect arrhythmia from data collected with these novel devices 4. Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation. CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues: 1. Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure? 2. What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF? 3. Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods? 4. Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tényleges)
- Első benyújtás
- 2022. ápr. 12.
- Kezdés
- 2022. ápr. 12.
- Elsődleges befejezés
- 2024. ápr. 23.
- Fő szponzor
- University of Turku
- Betegségek
- Pitvarfibrilláció, Stroke (szélütés)
- NCT-szám
- NCT05351775
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 150
- 2022. ápr. 12. és az elsődleges befejezés (2024. ápr. 23.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Permanent anticoagulation therapy due to atrial fibrillation
Más betegség
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Életkor
- Age < 18 years
Egyéb
- Expected survival < 1 year
- Patient lives outside the catchment area
Kiket keres a vizsgálat
- One of listed cardiac operation performed during the index hospitalization:
- open heart surgery (aortic valve replacement (AVR), coronary artery bypass graft (CABG) or combination treatment) or
- percutaneous intervention (transcatheter aortic valve implantation (TAVI) or percutaneous coronary intervention (PCI))
- Patient has been informed on the nature of the study, agrees to its provisions and has provided written informed consent approved by the appropriate Medical Ethics committee.
- In PCI group, the randomization may take place after operation
- Age ≥18 years
- CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and at least one of the following: ECG P wave duration ≥ 120 ms, left atrial diameter > 38 mm in women or > 40 mm in men, renal impairment (eGFR < 50 ml/min), age ≥ 70 years, active smoking
- Anticipated life expectancy 12 months or more
- Patient is capable of using the study application and bed sensor
- Patient is willing to comply with study specific follow-up evaluations and home-based monitoring
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Heart Center, Turku University Hospital | Turku | Finnország | Ismeretlen állapot |
Kapcsolódó publikációk
- Randomized trial of smartphone application and bed sensor for atrial fibrillation detection in high-risk patients.Sci Rep · 2026 · PMID 41634330
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.