RecruitingACTRN12622001521718

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


Sponsor

Concord Repatriation General Hospital

Enrollment

72 participants

Start Date

Mar 17, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Many people have chest pain or heart symptoms but when they undergo a coronary angiogram (an X-ray of the heart's arteries), no major blockages are found. This condition — called ischaemia with no obstructive coronary artery disease, or INOCA — is not well understood and often dismissed, leaving patients in a frustrating cycle of ongoing symptoms and no clear diagnosis or treatment. However, growing research shows that problems with how the small coronary blood vessels function may be to blame. The MAD-NOCA trial is testing whether performing detailed testing on all three major coronary arteries (rather than just one, which is standard practice) leads to more accurate diagnoses and better treatment decisions. The testing involves measuring blood flow and how the vessels respond to specific drugs while a pressure wire is temporarily placed in the heart's arteries. You may be eligible if you are 18 or older, have undergone a coronary angiogram that showed no significant blockages, and have symptoms such as chest pain at rest, new exertion-related pain, or have been found to have a heart muscle condition or abnormal heart rhythm alongside chest symptoms. You would not be eligible if you have had a heart attack in the past 7 days, are in cardiogenic shock, are pregnant or breastfeeding, have had a major operation in the past 6 weeks, or have contraindications to the drugs used in the testing.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Concord Repatriation Hospital - Concord

NSW, Australia

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12622001521718


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