ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07476859 (HI-COR-65) के लिए Acute Coronary Syndromes (ACS), लोहा की कमियाँ, Elderly (People Aged 65 or More) 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
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (HI-COR-65) चरण IV 538 रैंडमाइज़्ड ओपन-लेबल
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 NCT07476859 (HI-COR-65) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Acute Coronary Syndromes (ACS), लोहा की कमियाँ, Elderly (People Aged 65 or More) से जुड़ा हुआ है और यह एक चरण IV हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 5 मार्च 2026 को हुई थी, और इसमें कुल 538 प्रतिभागियों के नामांकन की योजना है। Fundación para la Investigación del Hospital Clínico de Valencia इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 मई 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 24 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The goal of this phase IV, open-label, randomized clinical trial is to evaluate whether intravenous iron improves quality of life in adults aged 65 years and older with iron deficiency after an acute coronary syndrome (ACS).
The main questions it aims to answer are:
- Does intravenous iron improve quality of life at 6 and 12 months?
- Does it reduce frailty and adverse clinical outcomes?
Researchers will compare i...
और दिखाएँविस्तृत विवरण
Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality in adults aged 65 years and older. Iron deficiency is a frequent condition in this population following an ACS event and has been associated with impaired functional capacity, increased frailty, worse quality of life, and poorer clinical outcomes. While intravenous iron supplementation has demonstrated clinical benefits in pati...और दिखाएँ
आधिकारिक शीर्षक
Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome
स्वास्थ्य स्थितियां
Acute Coronary Syndromes (ACS)लोहा की कमियाँElderly (People Aged 65 or More)अन्य अध्ययन आईडी
- HI-COR-65
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-03-05
अंतिम अद्यतन प्रकाशित
2026-03-24
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-05
नामांकन (अनुमानित)
538
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण IV
स्थिति
भर्ती जारी
प्रमुख शब्द
Acute coronary syndrome
Iron deficiency
Intravenous iron
Ferric carboxymaltose
Quality of life
Older adults
Myocardial infarction
Frailty
Cardiovascular outcomes
Biological aging
ELOVL2 methylation
Telomere length
Klotho
FGF23
Iron deficiency
Intravenous iron
Ferric carboxymaltose
Quality of life
Older adults
Myocardial infarction
Frailty
Cardiovascular outcomes
Biological aging
ELOVL2 methylation
Telomere length
Klotho
FGF23
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकIntervention arm Intravenous iron administered according to protocol and SmPC. | Ferric Carboxymaltose Injection [Ferinject] Intervention Description (Treatment Arm)
Single intravenous administration of ferric carboxymaltose (Ferinject®) given at baseline within 15 days after the index acute coronary syndrome. The total iron dose is individually calculated according to body weight and hemoglobin levels, in accordance with the approved Summary of Product Characteristics (maximum 15 mg/kg, not exceeding 2,000 mg). The drug is administered i...और दिखाएँ |
कोई हस्तक्षेप नहींControl arm No specific intervention for iron deficiency (standard of care post-acute coronary syndrome) | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change from baseline in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score | Change from baseline in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The EQ-5D-5L index score ranges from 0 to 1, where 0 represents the worst health state and 1 represents full health.
Higher scores indicate better health-related quality of life. Scores will be evaluated at 6 and 12 months and compared with baseline between participants receiving intravenous ferric carboxymaltose and those receiving no iron treatment. | Baseline, Month 6 and Month 12. |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale | Change from baseline in frailty status assessed using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale. The FRAIL scale classifies participants as robust, pre-frail, or frail based on questionnaire responses. | Baseline, Month 6 and Month 12. |
Incidence of heart failure hospitalization | Occurrence of hospitalizations due to decompensated heart failure during follow-up. | Up to 12 months |
Incidence of recurrent myocardial infarction | Occurrence of non-fatal myocardial infarction during follow-up. | Up to 12 months |
Incidence of stroke | Occurrence of ischemic or hemorrhagic stroke during follow-up. | Up to 12 months |
All-cause mortality | Death from any cause during the 12-month follow-up period. | Up to 12 months |
Change in C-reactive protein levels (inflammatory marker) | Change from baseline in C-reactive protein (CRP) levels. Units: mg/dl | Baseline and 12 months follow-up |
Change in high-sensitivity C-reactive protein levels (inflammatory marker) | Change from baseline in high-sensitivity C-reactive protein (CRP) levels. Units: mg/L | Baseline and 12 months follow-up |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
65 Years
अध्ययन के लिए पात्र लिंग
सभी
Age ≥ 65 years.
Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.
Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:
- Serum ferritin < 100 ng/mL, OR
- Transferrin saturation (TSAT) < 20%.
Ability to provide written informed consent prior to participation.
- Active malignancy.
- End-stage or terminal illness as determined by the IDC-Pal score.
- Known heart failure with left ventricular ejection fraction (LVEF) < 40% prior to enrollment, or development of LVEF < 40% during hospitalization or within 15 days after ACS.
- Chronic dialysis or advanced renal or hepatic failure.
- Severe anemia (hemoglobin < 10 g/dL) at the time of ACS or within 15 days after the event.
- Prior treatment with intravenous or oral iron within 12 months before the index ACS.
- Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
- Evidence of iron overload or disorders of iron metabolism.
- Ongoing bacteremia or active systemic infection.
- Participation in another interventional clinical trial involving an investigational medicinal product.
- Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.
Fundación para la Investigación del Hospital Clínico de Valenciaएस्ट्राजेनेकाअध्ययन केंद्रीय संपर्क
संपर्क: Clara Bonanad Lozano, Doctor, +34 686 10 70 71, [email protected]
संपर्क: Claudio Rivadulla Varela, Doctor, +34 625 11 46 86, [email protected]
9 1 देशों में अध्ययन स्थान
Murcia
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, 30120, Spain
María Asunción Esteve Pastor, Doctor, संपर्क, +34968381027, [email protected]
María Asunción Esteve Pastor, Doctor, मुख्य अन्वेषक
भर्ती जारी
Pontevedra
Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain
Sergio Raposeiras Roubin, Doctor, संपर्क, +34886209106, [email protected]
Sergio Raposeiras Roubin, Doctor, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं
Hospital Universitario de Badajoz, Badajoz, 06080, Spain
Javier Pérez Cervera, Doctor, संपर्क, +34637998882, [email protected]
Javier Pérez Cervera, Doctor, मुख्य अन्वेषक
भर्ती जारी
Hospital Clínic de Barcelona, Barcelona, 08036, Spain
Pedro Luis Cepas Guillén, Doctor, संपर्क, +34662038836, [email protected]
Pedro Luis Cepas Guillén, Doctor, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं
Hospital Universitario Clínico San Cecilio, Granada, 18016, Spain
Diego Segura-Rodríguez, Doctor, संपर्क, +34958023000, [email protected]
Diego Segura-Rodríguez, Doctor, मुख्य अन्वेषक
भर्ती जारी
Hospital Universitario de León, León, 24071, Spain
Maria Thiscal López Lluva, Doctor, संपर्क, +34 652 684 953, [email protected]
Maria Thiscal López Lluva, Doctor, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं
Hospital Clínico San Carlos, Madrid, 28040, Spain
David Vivas Balcones, Doctor, संपर्क, +34658477955, [email protected]
भर्ती जारी
Hospital Universitario de Navarra, Pamplona, 31008, Spain
Gonzalo Luis Alonso Salinas, Doctor, संपर्क, [email protected]
Gonzalo Luis Alonso Salinas, Doctor, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं
Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain
Clara Bonanad Lozano, Doctor, संपर्क, +34 686 10 70 71, [email protected]
Clara Bonanad Lozano, Doctor, मुख्य अन्वेषक
Claudio Rivadulla Varela, Doctor, उप-अन्वेषक
भर्ती जारी