Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain
Active, not recruitingNot applicableNCT07559994
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain: the Long Covid-19 INOCA Trial
- Conditions
- Angina (Stable)
- INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- Long COVID-19 Syndrome
- Interventions
- Diagnostic test: Coronary functional test
- Sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Collaborators
- Instituto de Salud Carlos III
- Start date
- 2021-09-02
- Primary completion
- 2025-04-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: \- All patients with the history of SARS-CoV-2 infection, either with acute infection confirmed by PCR or antigen testing, or with past infection demonstrated by serological testing, with symptoms suggestive of LCS such as post exertional malaise, persistent fatigue, difficulty concentrating or shortness of breath who present with typical angina or angina equivalent chest pain starting after SARS-CoV2 infection Exclusion Criteria: * Previously been diagnosed with coronary artery disease * Severe left ventricular systolic dysfunction (LVEF) \< 30% * Any moderate to severe concomitant structural heart disease (e.g. moderate to severe valvular heart abnormalities, severe left ventricular hypertrophy) * Severely reduced renal function (glomerular filtration rate \< 30 ml/min/1.73m2) * Contraindications to the administration of Adenosine or Acetylcholine * A life expectancy of less than 2 years
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07559994