iCorMicA - Stratified Medicine in Angina

Condition(s) studied

Investigational drug(s) / intervention(s)

Disclosure of IDP results: The results of the adjunctive IDP performed at time of invasive coronary angiography are made available to the catheter laboratory clinician, to aid in the diagnostic process.

IDP performed but results not disclosed: The results of the IDP performed at the time of invasive coronary angiography are concealed from the catheter laboratory clinician who will be blinded. The patient is managed according to standard of care.

Study summary

The iCorMicA study is a multicentre, prospective, randomised, double-blind, sham-controlled, parallel-group, end-point trial and registry. The investigators seek to determine whether stratified medical therapy guided by an adjunctive interventional diagnostic procedure (IDP) during the invasive management of patients with known or suspected angina but no obstructive coronary artery disease improves symptoms, wellbeing, cardiovascular risk and clinical outcomes.

Eligibility

Primary outcome measure(s)

• Seattle Angina Questionnaire (SAQ) Summary Score — 12 months
  The 7-item version of the SAQ reflects the frequency of angina (SAQ Angina Frequency score) and the disease-specific effect of angina on patients' physical function (SAQ Physical Limitation score) and quality of life (Quality of Life score) over the previous 4 weeks; these scores are averaged to obtain the SAQ Summary score, which is an overall measure of patients' stable ischaemic heart disease-specific health status. SAQ scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life.

Trial sites (39)

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