International study of coronary microvascular angina (iCorMicA): A registry-based diagnostic study and nested randomized trial.
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Ang Daniel, Young Robin, Taggart Diann, Carrick David, Chattopadhyay Sudipta, Raja Yogesh, Balachandran Kanarath, Elghamaz Ahmed, Greenwood John, Hoole Stephen, Cotton James, Choudhury Anirban, O'Kane Peter, Jadhav Sachin, Purcell Ian, Mitra Rito, Sabra Ahmed, Giblett Joel, Byrne Robert, O'Gallagher Kevin, Subkovas Eduardas, Rampat Rajiv, Anantharam Brijesh, Radhakrishnan Ashwin, Owens Colum, Damman Peter, Guzik Bartłomiej, Collison Damien, Howarth Fiona, Lennon Liz, Tolentino Patricia-Marielle, Vicere Andrea, Martin Kirsty, Kamdar Anna, Sykes Robert, Hanna Rebecca, Tan Dylan, Heggie Robert, Wu Olivia, Welsh Paul, Ford Thomas, Lang Chim Choy, Kunadian Vijay, McConnachie Alex, Berry Colin
Аннотация
METHODS: This is an international, multicenter, prospective, registry-based study and nested, randomized, controlled, triple-blind, and endpoint trial. Participants, community care providers, and outcomes assessors are masked. Consented participants enter the registry. Participants without obstructive coronary artery disease (luminal stenosis <50%, or fractional flow reserve >0.80) are eligible for randomization. Index of microcirculatory resistance (IMR; abnormal ≥25) and coronary flow reserve (CFR; abnormal <2.0; gray zone 2.0-2.5) are measured by bolus thermodilution, and results are disclosed (intervention) or not (control group) to the attending cardiologist.
RESULTS: The primary outcome of the registry is the Seattle Angina Questionnaire summary score at baseline described by coronary artery disease status. Secondary outcomes include the prevalence of obstructive coronary artery disease, patient reported outcome measures and clinical outcomes. The primary outcome of the randomized trial is the within-individual change in Seattle Angina Questionnaire summary score at 12-months from baseline. Secondary outcomes include safety, diagnostic accuracy, patient reported outcome measures for quality of life, physical and psychological function, cardiovascular risk, clinical outcomes, health economics and mechanistic biomarkers. The first patient was screened on December 18, 2020 and the last patient was enrolled on June 30, 2026. Forty sites were included in the United Kingdom (n = 35), Republic of Ireland (n = 2), Holland (n = 2), and Poland (n = 1). In total, 1,483 participants were enrolled into the registry of whom 1,047 were randomized and 386 were not randomized (registry-only).
CONCLUSION: This international, registry-based clinical trial will provide novel evidence on the natural history of angina and stratified therapy for angina with no obstructive coronary arteries.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04674449.
UNIQUE IDENTIFIER: NCT04674449.