رادار التجارب AI | ||
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حالة التجربة السريرية NCT05182970 (MIMET) لـ مرحلة ما قبل السكري، احتشاء عضلة القلب الحاد، احتشاء عضلة القلب غير المرتفع ST، احتشاء عضلة القلب مع ارتفاع مقطع ST هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
معهد كارولنسكاMetformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05182970 (MIMET) مصممة لدراسة وقاية لـمرحلة ما قبل السكري، احتشاء عضلة القلب الحاد، احتشاء عضلة القلب غير المرتفع ST، احتشاء عضلة القلب مع ارتفاع مقطع ST. إنها تجربة تدخُّلية من المرحلة الثالثة وهي قيد التجنيد. بدأت في ٢٧ ربيع الآخر ١٤٤٣ هـ مع خطة لتجنيد ٥٬١٦٠ مشاركًا. تقودها معهد كارولنسكا، ومن المتوقع اكتمالها بحلول ١٤ ذو القعدة ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٣ رمضان ١٤٤٥ هـ.
الملخص
Prediabetes is associated to an increased risk of cardiovascular disease and mortality. Although metformin can delay progression to diabetes there is a lack of RCTs evaluating the effect of metformin on cardiovascular outcomes. MIMET aims to investigate if addition of metformin to standard care has effects on the occurrence of cardiovascular events after acute myocardial infarction in patients with newly detected prediabetes (identified by oral glucose tolerance test, HbA1c or fasting glucose levels).
وصف مفصل
The study is a national multicenter R-RCT associated to the The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART registry) where participants, after informed consent, will be randomly assigned to either open treatment with standard care + metformin or standard care alone in a 1:1 ratio. Standard care consists of diet and life-style advice according to national guidelines but does not include metformin. Baseline data for individual patients will be collected from the SWEDEHEART registry. Patients will be followed per routine care at 2 and 12 months post index AMI and in addition at a final study visit at 24 months. Laboratory measurements and collection of SAE will be performed yearly. In total n=5150 patients is expected to be followed for major CV event (all-cause mortality, myocardial infarction, heart failure and stroke) by linkage with SWEDEHEART and national health registries.
العنوان الرسمي
The Myocardial Infarction and New Treatment With Metformin Study (MIMET) - a R-RCT to Study Metformin and the Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Newly Detected Prediabetes
الحالات الطبية
مرحلة ما قبل السكرياحتشاء عضلة القلب الحاداحتشاء عضلة القلب غير المرتفع STاحتشاء عضلة القلب مع ارتفاع مقطع STالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- MIMET
- 2019-05382
NCT معرّف
تاريخ البدء (فعلي)
2021-12-02
آخر تحديث مُنشور
2024-04-02
تاريخ الاكتمال (المقدر)
2026-05
عدد المشاركين المخطط لهم
٥٬١٦٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثالثة
الحالة
قيد التجنيد
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
مقارن نشطMetformin on top of standard care Metformin will be prescribed by the Investigator at the study site and dispensed at pharmacy of choice by the patient. Metformin will be recommended to be gradually titrated to minimize gastrointestinal side effects with a start dose of 500 mg 1x1 for 1 week and thereafter 500 mg 1x2 with an individualised target dose of 2000 mg daily depending on tolerability. The goal is to a have minimal dose of 500 mg 1x2. Patients will be informed to stop medication in events of sever nausea, vomiting or dehydration according to standard practice. The threshold for metformin titration or adding another drug during follow-up is recommended to be assessed individually by the Investigator at the study site, responsible for the patient. Patients with eGFR \<60 cannot be included in the MIMET study. If GFR is between 30-45 ml/min during the study, metformin should be reduced to 1000 mg daily. Metformin is contraindicated if GFR \<30 ml/min. Standard care will be the same as in the control arm. | ميتفورمين Individualised target dose of 2000 mg daily depending on tolerability. |
بدون تدخلStandard care alone Standard care according to national guidelines. In Sweden there is no pharmacological intervention recommended for individuals with prediabetes at present. Standard care includes diet and life-style advice, which will be given to both groups in the same manner according to local routines, based on the present guidelines. Secondary preventive treatment includes physical activity, participating in exercise program, dietary habits, BMI and or waist circumference, smoking and EQ-5D will be followed in accordance with the routinely reported SWEDEHEART-SEPHIA variables. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Time to major CV event | Major CV event; a composite endpoint of first of all-cause death or main diagnosis of MI, heart failure or stroke (reported in SWEDEHEART, the National Patient Register and the Cause of Death Register). | Estimated follow-up for each patient is 1-4 years |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Time to the composite endpoint CV death, main diagnosis of MI, heart failure or stroke. | Time to first event included in the composite endpoint CV death, main diagnosis of MI, heart failure or stroke. | Estimated follow-up for each patient is 1-4 years |
Time to the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI >4 months after the index AMI). | Time to first event included in the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI \>4 months after the index AMI). | Estimated follow-up for each patient is 1-4 years |
All-cause death | Time to all-cause death | Estimated follow-up for each patient is 1-4 years |
CV death | Time to CV death | Estimated follow-up for each patient is 1-4 years |
Hospitalisation with MI | Time to readmission for MI. Hospital admission for MI during day 0-30 after index AMI will be excluded | Estimated follow-up for each patient is 1-4 years |
Hospitalisation with stroke | Time to hospitalisation for stroke (main diagnosis) | Estimated follow-up for each patient is 1-4 years |
Hospitalisation with heart failure | Time to hospitalisation for heart failure (main diagnosis) | Estimated follow-up for each patient is 1-4 years |
New cancer diagnosis | Time to new cancer diagnosis defined as the first occurrence of any cancer in the National Patient Register | Estimated follow-up for each patient is 1-4 years |
Initiation of any glucose lowering therapy | Time to initiation of any glucose lowering therapy (ATC code A10 in the Prescribed Drug Register, excluding randomisation to metformin) | Estimated follow-up for each patient is 1-4 years |
Diabetes diagnosis | Defined as diabetes diagnosis in National Patient Register and/or prescribed glucose lowering treatment in the Prescribed Drug Register excluding randomisation to metformin in the active treatment arm | Estimated follow-up for each patient is 1-4 years |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
I. AMI
II. Swedish citizens with a personal ID number ≥18 years and ≤80 years
III. Newly diagnosed prediabetes:
- HbA1c 42-47 mmol/mol or
- Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
- 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
- 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/L
- HbA1c <48 mmol/mol and 2-hour post-load capillary glucose concentration >12.1 mmol/L or 2-h post-load venous plasma glucose concentration >11.0 mmol/L (thus elevated 2-hour glucose levels in the diabetes range but without HbA1c levels diagnostic for diabetes)
IV. Naïve to metformin and other glucose lowering therapy
V. Signed informed consent
I. Type 1 diabetes
II. Known type 2 diabetes
III. Indication for glucose lowering treatment
IV. Acute condition with high risk for volume depletion, circulatory shock, hypoxia
V. Serious illness, other than cardiovascular, with short life expectancy
VI. Renal failure (eGFR <60ml/min)
VII. Hepatic failure
VIII. Malignancy within the last year
IX. Contraindication or hypersensitivity to the study drug
X. Alcohol or drug abuse
XI. Pregnancy or breastfeeding
XII. Women of childbearing potential without adequate anticonception during any part of the study period
XIII. Previous hospitalisation for lactic acidosis
XIV. Predicted inability to comply with the study protocol
معهد كارولنسكا- 🏥Capio Sankt Görans Hospital
جامعة أبسالة219 تجارب سريرية نشطة للاستكشاف- 🔬The Swedish Research Council
الجهة المسؤولة عن الدراسة
Anna Norhammar, المحقق الرئيسي, Professor, Karolinska Institutet
جهة اتصال مركزية للدراسة
جهة اتصال: Anna Norhammar, MD, Prof., +46858701568, [email protected]
جهة اتصال: Viveca Ritsinger, MD, PhD, +46372585000, [email protected]
1 مواقع الدراسة في 1 بلدان
Medicinkliniken, Ljungby Hospital, Ljungby, 341 35, Sweden
Thomas Aronsson, Head of Clinic, جهة اتصال
Viveca Ritsinger, MD PhD, المحقق الرئيسي
قيد التجنيد