Multivessel compared to Single Vessel Functional Angiography to Diagnose Patients with No Obstructive Coronary Artery Disease: The MAD-NOCA trial
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 Hospital
72 participants
Mar 17, 2022
Interventional
Conditions
Summary
Patients with Ischaemia and No Obstructive Coronary Artery Disease (INOCA) are under-diagnosed and under-treated in current clinical practice. There is a growing body of evidence that pathological abnormalities in coronary vessels characterise these conditions, leading to increased morbidity and mortality. These patients continue to experience recurrent angina, a poor quality of life and adverse cardiovascular outcomes. Although there is growing recognition of the impact of this entity amongst the cardiology community, methods and criteria pertaining to the diagnosis remain poorly defined. The MAD-NOCA trial (Multivessel compared to Single-vessel Functional Angiography to Diagnose Patients with No Obstructive Coronary Artery Disease) aims to develop a novel diagnostic algorithm for patients with INOCA. This randomised controlled trial will evaluate whether comprehensive three-vessel coronary physiology and vasoreactivity testing, compared to standard single vessel testing, in patients with INOCA, will: 1) Increase the proportion of patients diagnosed with a ‘disorder of coronary vasomotion’, 2) Influence clinical management, 3) Lead to improved clinical outcomes
Eligibility
Inclusion Criteria8
- 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 Criteria12
- 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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Interventions
Multivessel functional angiography - Qualified study personnel will complete coronary physiology and vasoreactivity testing (with intracoronary acetylcholine) to assess the coronary microcirculation and propensity for coronary vasospasm. Vasoreactivity testing will include incremental doses of acetylcholine (20/50/100/200mcg into the left coronary system and 20/50/80mcg into the right coronary system, respectively) - All 3 major epicardial coronary arteries (left anterior descending, left circumflex and right coronary artery) will be assessed. - This intervention will occur in the cardiology catheterization lab and be delivered once during the study period. - The intervention will take approximately 45 minutes to complete
Locations(2)
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ACTRN12622001521718