EUCTR2012-002563-10-GB进行中（未招募）1 期
Multicenter open-label study to evaluate efficacy of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known or suspected CAD by a blinded image analysis - GadaCAD 1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 426
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Male or female subjects aged =18 years
- •- Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention or CTA within 4 weeks around gadobutrol-enhanced CMRI
- •- Willingness to undergo stress/rest CMRI and to follow directions and complete all study procedures
- •- Women of childbearing potential (e.g. age < 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •- Pregnant or nursing (including pumping for storage and feeding)
- •- Received any other investigational product or participation in any other interventional clinical study within 15 days prior to enrollment in this study
- •- Suspected clinical instability or unpredictability of the clinical course during the study period
- •- Any scheduled procedure such as interventional (PCI, stenting) or surgical treatment that may alter/may have altered the cardiac condition regarding myocardial perfusion status and/or stenosis degree between CMRI and CA or CTA.
- •- Any contrast agent +/- 24 h prior to or after gadobutrol-enhanced CMRI (i.e. ensure minimum interval of 24 h between the SoR and the CMRI). This does not apply for emergency CA.
- •- Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe arrhythmias preventing gated acquisition; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI, such as pace makers)
- •- History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator’s assessment / judgment
- •- Estimated glomerular filtration rate (eGFR) value <30 mL/min/1.73 m2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment.
- •- Acute renal insufficiency
- •- Previous enrollment into this study or any other Bayer-sponsored study using gadobutrol
- •- Coronary artery bypass grafting (CABG)
- •- Acute myocardial infarction (< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure, decompensated heart failure with ejection fraction <35%
- •- Irregular heart rhythm
- •- Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease
- •- Uncontrolled and severe hypertension
- •- Baseline hypotension
- •- Subject has a close affiliation with the investigational site; e.g. a relative of the investigator, or a dependent person.
研究者
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