Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- On CMR; left ventricle peak filling rate (ml/s)
研究概览
简要总结
The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.
This study project sets out to answer the following hypotheses:
- Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.
- Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient fully capable of informed consent
- •Informed consent
- •Age 18-80 (both years included)
排除标准
- •Contraindications to CMR (pacemakers/ICD-units, cochlear implants)
- •Lack of consent
- •Atrial fibrillation
- •eGFR < 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study)
- •Women of childbearing potential who are not on acceptable contraception
- •Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations)
- •Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure
- •Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
结局指标
主要结局
On CMR; left ventricle peak filling rate (ml/s)
时间窗: Cross-sectional so at baseline
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
On CMR, LV myocardial perfusion
时间窗: Cross-sectional so at baseline
Including measurements at rest and with Adenosin stress
On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function
时间窗: Cross-sectional so at baseline
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
次要结局
- Echocardiography(Cross-sectional so at baseline)
- Blod samples(Cross-sectional so at baseline)
研究者
Annemie Stege Bojer
Clinical assistant
Slagelse Hospital