ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT06555757 (STEREO) के लिए हृदय विफलता वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation (STEREO) 250 गैर-आक्रामक (Non-invasive) सवैतनिक भागीदारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06555757 (STEREO) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो हृदय विफलता से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 250 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 15 अगस्त 2024 से शुरू होगा। Cambridge University Hospitals NHS Foundation Trust इस परीक्षण का नेतृत्व कर रहे हैं और इसके 15 अगस्त 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 15 अगस्त 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Heart failure impacts more than 2% of people in the UK (United Kingdom) and leads to about 5% of emergency hospital visits. Patients might have slowly worsening symptoms or suddenly face acute decompensated heart failure (ADHF), marked by intense difficulty in breathing due to fast-developing lung congestion. This is a serious emergency requiring in-hospital treatment and monitoring. Once stable, patients usually hav...और दिखाएँ
विस्तृत विवरण
Heart failure is a common condition in which the heart is unable to deliver the desired cardiac output either due to a weakened or stiff heart muscle. It affects more than 2% of the UK population (the incidence is around 200,000 cases per annum) resulting in 5% of all the emergency hospital admissions and it consumes approximately 2% of the annual NHS budget (approximately £2 billion per annum). Therefore, heart fail...और दिखाएँ
आधिकारिक शीर्षक
Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation
स्वास्थ्य स्थितियां
हृदय विफलताअन्य अध्ययन आईडी
- STEREO
- STEREO (A096862)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-08-15
अंतिम अद्यतन प्रकाशित
2024-08-15
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-08-15
नामांकन (अनुमानित)
250
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
heart failure
cardiovascular
artificial intelligence
cardiovascular
artificial intelligence
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
Patients with heart failure Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology/heart failure clinic visit, or ADHF during recent/current hospitalization). | Height, weight, and BMI Height, weight measurement and BMI calculation Medical history Brief medical history including medications/allergies and heart failure related healthcare utilisation over previous 12 months शारीरिक परीक्षण Brief physical examination Venous blood samples Venous blood samples, to include WCC, HB, CRP and NTproBNP Resting vital signs HR, BP, RR, oxygen saturations on air) ट्रांसथोरेसिक इकोकार्डियोग्राम LVEF, IVC collapsibility, LV filling pressure, PA pressure Sound recordings Sound recordings (voice/cough/chest) recorded with the in-built microphone in a smartphone फेफड़े का अल्ट्रासाउंड Lung ultrasound KCCQ questionnaire Kansas City Cardiomyopathy Questionnaire ASCEND-HF score An in-hospital congestion score which risk stratifies patients admitted with worsening heart failure, developed for the Acute study of clinical effectiveness of Nesiritide in decompensated heart failure trial Composite Everest congestion score A shortened version of the original 18-point score from the EVEREST trial Bio impedance and total body water measurement Bio impedance and total body water measurement using TANITA device |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Area under receiver operating curve (AUC) | The maximum value is "1", describing ability of the AI algorithm to discriminate between dry and congested lungs | Up to 48 months for data collection (includes part A (pilot) + part B (definitive study)) |
Negative and positive predictive value (NPV and PPV) | NPV and PPV describe the proportions of the positive (congested lungs) and negative (dry lungs) results predicted by the AI algorithm that are true results | Up to 48 months for data collection (includes part A (pilot) + part B (definitive study)) |
Sensitivity | The ability of the AI algorithm to correctly identify when a heart failure patient has pulmonary congestion | Up to 48 months for data collection (includes part A (pilot) + part B (definitive study)) |
Specificity | The ability of the AI algorithm to correctly identify when a heart failure patient has no pulmonary congestion (dry lungs) | Up to 48 months for data collection (includes part A (pilot) + part B (definitive study)) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Weight | Kg | Delta congested (during HF decompensation) vs dry lungs (baseline) |
NTproBNP | Ng/L | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Heart rate | beats/minute | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Respiratory rate | breaths/min | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Blood pressure | mmHg | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Oxygen saturation (on air) | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Left ventricular ejection fraction (ECHO) | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Inferior vena cava collapsibility (ECHO) | mm | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Left ventricular filling pressure (ECHO) | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Pulmonary artery pressure | Low, intermediate and High probability with combination of different echo parameters (Tricuspid regurgitation velocity, Pulmonary artery acceleration time, right heart size \& pulmonary artery size) | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Speech biomarker - Fundamental frequency | Hz | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Speech biomarker - Jitter and Shimmer | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Speech biomarker - Pause duration | ms | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Speech biomarker - Mel Frequency Spectral Coefficients | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
KCCQ (Kansas City Cardiomyopathy Questionnaire) questionnaire | Overall scaled score (0-100) - higher score, better health status.
Average scores for each of the domains will also be calculated/ analysed separately | Delta congested (during HF decompensation) vs dry lungs (baseline) |
ASCEND-HF score | An in-hospital congestion score which risk stratifies patients admitted with worsening heart failure, developed for the Acute study of clinical effectiveness of Nesiritide in decompensated heart failure trial
1-8 (higher score - increased congestion) | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Composite Everest congestion score | A shortened version of the original 18-point score from the EVEREST trial
0-9 (higher score-increased congestion) | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Physiological measures derived from a patient's own pacemaker or CRT device (such as thoracic impedance) | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Bio-Impedance (TANITA) | Ohms | Delta congested (during HF decompensation) vs dry lungs (baseline) |
Total body water (TANITA) | Delta congested (during HF decompensation) vs dry lungs (baseline) | |
Number of General Practitioner (GP) reviews | Number of GP reviews for heart failure exacerbations /12 months | 12 months |
Number of heart failure specialist nurse reviews | Number of heart failure specialist nurse reviews / 12 months | 12 months |
Number of A&E presentations for heart failure exacerbation | Number of A\&E presentations for heart failure exacerbation / 12 months | 12 months |
Total overnight hospital admissions due to HF exacerbations | Total overnight hospital admissions / 12 months due to heart failure exacerbations | 12 months |
Total days admitted as inpatient in hospital due to HF exacerbation | Total days admitted as inpatient in hospital due to HF exacerbation over last 12 months | 12 months |
8-point method to detect pulmonary congestion (lung US) | Count of B-lines in each of the 8 zones | Delta congested (during HF decompensation) vs dry lungs (baseline) |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Male or Female, aged 18 years or above.
- Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology/heart failure clinic visit, or ADHF during recent/current hospitalization).
- Participant is willing and able to give informed consent for participation in the study.
- Participant has a smartphone device and can download a purposely designed mobile application on their phone (with guidance from the study investigators) or is willing to have sound recordings via a smartphone device loaned for the purpose of the study.
- Unable to provide consent
- Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
- Patients with currently known pneumonia
- Patients with known significant pulmonary disease including asthma, COPD, pulmonary fibrosis/interstitial lung disease, pulmonary hemorrhage.
- Patients with current Pulmonary embolus
- Patients with other intercurrent acute symptomatic illness (e.g., viral/bacterial infection) at time of recording
- Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
- Patients with tracheostomy or who have undergone a surgical procedure to the head/neck/larynx which would affect the normal functioning of the vocal cords.
- Aphasic
- Patients excluded at PI discretion
Cambridge University Hospitals NHS Foundation TrustUniversity of Cambridgeअध्ययन उत्तरदायी पक्ष
Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC, मुख्य अन्वेषक, Consultant Clinical Pharmacologist/Affiliated Associate Professor, Cambridge University Hospitals NHS Foundation Trust
अध्ययन केंद्रीय संपर्क
संपर्क: Erdem Demir, 01223 256621, [email protected]
संपर्क: Heike Templin, 01223 250874, [email protected]
कोई स्थान डेटा नहीं।