Multivessel compared to single vessel functional angiography to diagnose a disorder of coronary vasomotion and predict clinical outcomes in patients with no obstructive coronary artery disease: The MAD-NOCA trial

Concord Repatriation General Hospital0 个研究点目标入组 72 人开始时间: 2022年12月7日最近更新: 2024年1月22日

适应症

试验速览

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•Adult men and women aged over 18
•Clinically referred for coronary angiography
•Coronary angiography diagnosis of non-obstructive coronary arteries (<50% stenosis of a major epicardial vessel or a FFR >0.8)
•Acute or subacute ischemic symptoms such as chest pain or anginal equivalent symptoms at rest or new onset exertional angina
•Symptoms of atypical chest pain which is difficult to characterise
•Underlying diagnosis of a cardiomyopathy, valvular heart disease or arrhythmia
•Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances
•Able to personally read and understand the Participant Information and Consent Form and provide written, signed and data informed consent to participate in study (health care interpreters will be engaged for people with cultural and linguistically diverse backgrounds).

•Cardiogenic shock
•Coronary angiography revealing obstructive coronary arteries (above or equal to 50% stenosis)
•Myocardial infarction within 7 days
•Severe obstructive airways – any prior admission to ICU or general hospital admission in the past 12 months for infective exacerbation of airways disease.
•Active internal bleeding or history of haemorrhagic diathesis (including heparin-induced thrombocytopenia)
•Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (less than or equal to 1 month)
•Major Surgery (e.g., Coronary Artery Bypass Graft [CABG]) or trauma within the previous 6 weeks
•Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration (this is routine practice prior to coronary angiography).
•Inability to provide informed consent (compromised mental status e.g., dementia, too ill) for clinically indicated coronary angiography
•Currently a prisoner (has been admitted to hospital via a correctional facility)
•Contraindications to drugs and devices (Adenosine, Glyceryl Trinitrate [GTN], Acetylcholine)
•Heavily calcified or tortuous vessels leading to inability to advance pressure wire

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