ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07415447 (EVACaRe) के लिए कार्डियक फेल्योर, महाधमनी रोग वर्तमान में भर्ती जारी 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
Cardiac Remodelling Following Endovascular Repair of the Aorta (EVACaRe) 40
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 NCT07415447 (EVACaRe) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो कार्डियक फेल्योर, महाधमनी रोग से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 1 सितंबर 2025 को हुई थी, और इसमें कुल 40 प्रतिभागियों के नामांकन की योजना है। Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 सितंबर 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 17 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
To assess the effects of endovascular aortic repair on cardiac morphology and function
विस्तृत विवरण
After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.
The same evaluation will be performed at 6- and 12-months post-surgery.
आधिकारिक शीर्षक
Cardiac Remodelling Following Endovascular Repair of the Aorta
स्वास्थ्य स्थितियां
कार्डियक फेल्योरमहाधमनी रोगअन्य अध्ययन आईडी
- EVACaRe
- 2023.15211.PEX
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-09-01
अंतिम अद्यतन प्रकाशित
2026-02-17
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-09-01
नामांकन (अनुमानित)
40
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
cardiac
failure
aortic
disease
failure
aortic
disease
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
Participants submitted to aortic repair Participants submitted endovascular repair of the aorta | cardiac magnetic ressonance In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period. | The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR. | 12-month period |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period. | The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline and 6 months, measured in grams/mililiters/percentage through CMR and ECHO. | 6-month period |
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period. | The cardiac remodelling will be estimated through the variables of left ventricular volume/strain at baseline and 12 months, measured in mililiters/percentage through CMR and ECHO. | 12-months period |
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods. | The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline, 6 months and 12 months, measured in grams/mililiters/percentage through CMR and ECHO. | 6- and 12-months periods |
To correlate heart proximity and endograft extension with cardiac remodelling variables. | The cardiac remodelling will be correlated with the proximity and extension of aortic endografts, measured in milimeters, throught the analysis of the previously described cardiac remodelling variables and the analysis of CT scans. | 12-month period |
To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months | The cardiac biomarker will be obtained thorught blood sample analysis at 6-months and 12-months, comprised by the following:
Soluble suppression of tumorigenicity-2 (sST2). Collagen synthesis biomarkers (PICP, PINP, PIIINCP, PIIINP). Collagen type I degradation biomarker (CITP). B-type natriuretic peptide and terminal of the prohormone brain natriuretic peptide (BNP, NT-proBNP).
High sensitivity C Reactive protein (hsCRP). Galectin 3 (Gal3). Fibroblast activation protein (FAP). Troponins (I and T). Proteinomic and metabolomic parameters | 6-month and 12-month periods |
To compare the agreement between measurements ECHO and CMR measurements. | 12-month period | |
To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR. | The patient's blood pressure will be evaluated in clinical visits at 1-month, 6 months and 12 months, mesured em mmHg. | 1-month, 6-months and 12-month period. |
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
- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.
- Heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV.
- LV wall motion abnormality.
- Moderate to severe valve disease.
- History of (or expected within the study period) cardiac/aortic surgery.
- Coronary artery disease.
- Atrial fibrillation.
- Congenital heart disease.
- Connective tissue disorders.
- Chronic kidney disease (eGFR <30 mL/min/173 m2).
- Moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnoea Scale (mMRC) 3-4.
- CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboaअध्ययन उत्तरदायी पक्ष
Augusto Ministro, मुख्य अन्वेषक, Principal Investigator, Academic and Clinical Professor, Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
अध्ययन केंद्रीय संपर्क
संपर्क: Augusto Ministro Augusto Ministro, 00531 210405814, [email protected]
2 1 देशों में अध्ययन स्थान
Unidade Local de Saúde Santa Maria, Lisbon, 1649-028, Portugal
CIC, संपर्क, +351961948653, [email protected]
भर्ती जारी
Unidade Local de Saúde de Santa Maria, E.P.E., Lisbon, Portugal
अभी भर्ती शुरू नहीं