Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Coronary functional test: CFT will be reported as follow: 1) normal coronary functional testing 2) vasomotor disorder (including both epicardial and microvascular) 3) coronary microvascular dysfunction (including both structural and functional) and 4) combined vasomotor disorder and coronary microvascular dysfunction.

Study summary

Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study. Its objective is to investigate the benefits of tailored medical therapy according to the results of the coronary functional testing (CFT) against the routine standard of care and the prevalence and endotypes of ischemia with non-obstructive coronary arteries (INOCA) in patients with long covid-19 syndrome (LCS) and new onset chest pain. All LCS patient with new onset of chest pain will be enrolled. Invasive coronary angiogram and epicardial physiological assessment will be performed to exclude significant epicardial coronary artery disease. Patients without significant epicardial coronary artery disease will undergo CFT which include Acetylcholine test and Coronary microvascular function test. Patients will be randomized into 2 groups: 1) tailored treatment group guided by the results of CFT (intervention) and 2) the routine standard of care group (sham). All patients will undergo the angina symptom and the quality-of-life (QoL) assessment at baseline, 3, and 12 months using the Seattle Angina Questionnaire (SAQ). In the sham group, patients and physicians will be blinded to the results of coronary functional testing for 3 months. Treatment of INOCA will be provided in both groups. The main hypothesis of the Long-Covid INOCA study states that, in LCS patients with chest pain, treatment guided by CFT will demonstrate better angina symptom control and improvement in quality of life (QoL) comparing to the routine standard of care.

Eligibility

Primary outcome measure(s)

• The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group — From the date of enrollment to the end of follow up period at 12 months
  The Seattle Angina Questionnaire (SAQ) measures 5 dimensions of coronary artery disease (physical limit, stability, frequency, satisfaction, disease perception) on a 0-100 scale, where higher scores indicate better health status. Scores are interpreted as: 0-24 (Poor), 25-49 (Fair), 50-74 (Good), 75-100 (Excellent).

Trial sites (1)

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