Multivessel compared to Single Vessel Functional Angiography to Diagnose Patients with No Obstructive Coronary Artery Disease: The MAD-NOCA trial

Not Applicable

Recruiting

• Conditions: Angina; Coronary ischaemia; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12622001521718
• Lead Sponsor: Concord Repatriation General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-07
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

•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).

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seattle angina questionnaire (SAQ) score[ 6 months (primary endpoint) and 12 months post-angiography];The proportion of patients diagnosed with a disorder of coronary vasomotion. <br>- This will be based on coronary angiographic criteria through a review of this angiographic data.[ 6 months (primary endpoint) and 12 months post-angiography]