DRKS00032309招募中不适用
AI for the Prediction of Obesity-Related Vascular Diseases (AI-POD) - Validation study - AI-POD
Klinik für diagnostische und interventionelle Radiologie0 个研究点目标入组 1,200 人开始时间: 2024年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45 Years 至 one（—）
- 性别
- All
入选标准
- •? Age greater than or equal to 45 years at the time of signing informed consent
- •? BMI greater than or equal to 30 kg/m2
- •?Subjects with intermediate-to-high clinical likelihood of CAD, including:
- •- Those with suspected coronary artery disease (CAD) in symptomatic patients in whom CAD cannot be excluded by clinical assessment alone (> 15% pre-test probability for obstructive CAD based on age, sex, and nature of symptoms according to 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes (see supplemental Table 1).
- •oPossible conditions are:
- •?Men with typical angina pectoris symptoms = 40 years
- •?Women with typical angina pectoris symptoms = 60 years
- •?Men with atypical angina pectoris symptoms = 50 years
- •?Women with atypical angina pectoris symptoms = 70 years
- •?Men with non-anginal symptoms = 60 years
- •?Men with dyspnoea only or dyspnoea as the primary symptom = 50 years
- •oOr those with an overall > 15% clinical likelihood of obstructive CAD based on additional consideration of risk modifiers of the PTP estimate (including CVD risk factors, abnormal resting/exercise ECG or LV dysfunction according to 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes (see supplemental Table 2).
- •? Informed consent of the patient
排除标准
- •General Safety concerns:
- •? Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,
- •hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.
- •? Planned coronary, carotid, or peripheral artery revascularization known on the day of inclusion
- •? Presently classified NYHA IV heart failure
- •? Having uncontrolled diabetes mellitus (HbA1c = 11%) at day of inclusion
- •? Having uncontrolled hypertension (SBP = 160 mmHg and/or DBP = 100 mmHg) as measured at inclusion
- •? Having severe renal impairment measured as an eGFR < 30 mL/min/1.73 m2 at inclusion
- •? Alanine aminotransferase (ALT) or alkaline phosphatase (APT) level < 3.0 x the upper limit of normal (ULN)
- •for the reference range
- •? Total bilirubin level >1.5 x the ULN for the reference range
- •? History of an active or untreated malignancy or are in remission from a clinically significant malignancy for
- •less than 5 years
- •? Previous organ transplantation or awaiting an organ transplant
- •? Pregnancy or breastfeeding
- •Study-goal-directed criteria:
- •? Established CVD as evidenced by at least one of the following events: a history of myocardial infarction,
- •coronary artery stenting, coronary artery bypass grafting, stroke, or symptomatic peripheral arterial disease
- •(PAD) (as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 at rest), or
- •peripheral arterial revascularization procedure.
- •? Within the past 3 months previously participated in a weight-loss program
- •? Are currently enrolled in any other clinical study involving an investigational product or any other type of
- •medical research judged not to be scientifically or medically compatible with this study
- •? Are receiving or have received within 3 months prior to screening chronic (> 2 weeks) systemic glucocorticoid
- •therapy (excluding topical, intraocular, intranasal, intraarticular or inhaled preparations) or have evidence of an
- •active autoimmune abnormality that has required (within the last 3 months) or is likely to require, in the
- •opinion of the investigator, concurrent treatment with systemic glucocorticoids
- •? Have overweight or obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed
- •monogenetic or syndromic forms of obesity (i.e. Prader Willi Syndrome, Melanocortin 4 Receptor deficiency)
- •? Have a self-reported change in body weight > 5 kg within 3 months prior screening
- •? Have a prior or planned endoscopic, device-based or surgical treatment for obesity during the expected
- •timeline of the study
- •? Have a history of any other condition (i.e. drug or alcohol abuse, diagnosed eating disorder, or other psychiatric
- •disorder) that, in the opinion of the investigator, may preclude the participant from completing the protocol
- •? Known allergic reactions to CT contrast media
研究者
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