EUCTR2018-003518-41-NL进行中（未招募）1 期
Efficacy of Diltiazem to improve coronary microvascular dysfunction: A randomized clinical trial - EDIT-CMD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 142
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
- •1.Patients above the age of 18.
- •2.Patients with chronic angina, defined as symptoms of angina at least 2 times a week despite medical therapy for the last 3 months.
- •3.No signs of obstructive coronary artery disease (CAD), documented within 5 years* before inclusion by one of the following modalities:
- •a.Coronary angiography: patients with non-obstructive (<50% stenosis) coronary arteries are eligible, or patients with intermediate stenosis (between 50 and 70%) with documented FFR >0.80 or iFR >0.89 on angiogram. In patients with a history of stenting are eligible if they have no current significant coronary epicardial stenoses, a minimum diameter stenosis of <10% is required.
- •b.Coronary computed tomography angiography (CCTA) with finding of non-obstructive coronary arteries
- •4.Baseline coronary reactivity testing with at least one of the following:
- •a.CFR = 2.0
- •b.IMR = 25
- •c.Abnormal acetylcholine test defined as the presence of (recognizable) angina, ischemic ECG abnormalities with or without epicardial spasm
- •5.Signed written informed consent
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1.Other cause of angina deemed highly likely by the treating physician.
- •2.Active use of non-dihydropyridine calcium channel blockers or any use of non-dihydropyridine calcium channel blockers in the previous month or known intolerance for non-dihydropyridine calcium channel blockers.
- •3.Left ventricular ejection fraction < 50%.
- •4.Recent PCI within the past 3 months.
- •5.Patients with history of coronary artery bypass grafting (CABG).
- •6.Surgically uncorrected significant congenital or valvular heart disease, cardiomyopathy or myocarditis.
- •7.Significant renal impairment (eGFR < 30).
- •8.Significant hepatic impairment (history or cirrhosis or abnormal serum ALT or AST 3-fold greater than the upper limit of normal).
- •9.Pregnant women or women of child bearing potential who are planning to become pregnant within the next 3 months.
- •10.Prior non-cardiac illness with an estimated life expectancy < 1 year.
- •11.Contra-indication to coronary reactivity testing:
- •a.Contraindication or known hypersensitivity to adenosine.
- •b.Contraindication or known hypersensitivity to acetylcholine.
- •c.Contraindication to aminophylline.
- •d.Ongoing dipyridamole treatment.
- •12.Contra-indication for treatment with CCB: second or third degree AV block, sinus node dysfunction and/or bradycardia (heart rate < 40 beats/minute)
- •13.Symptomatic hypotension or systolic BP < 100 mmHg at screening visit on 2 consecutive measurements.
- •14.History of hospitalization for asthma and/or current use of = 2 types of pulmonary medications for asthma and/or severe COPD with FEV1 < 50% of predicted.
- •15.Participation in another clinical study with an IMP during the lastwithin one month prior to enrollment.
- •16.Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
- •17.Unable to give informed consent (i.e. due to language barrier).
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