An interventional study of Coronary functional test in Angina (Stable), INOCA (Ischemia With Non Obstructive Coronary Artery Disease) and Long COVID-19 Syndrome, sponsored by Fundacion Investigacion Interhospitalaria Cardiovascular. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Fundacion Investigacion Interhospitalaria Cardiovascular · Not applicable, Interventional, and Treatment
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.
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study intended to compare the benefits in angina symptom and Quality of Life assessed by the Seattle Angina Questionnaire (SAQ) between tailored medical therapy guided by the results of the coronary functional testing (CFT) and the routine standard of care in patient with LCS and new onset of chest pain. Secondary objective is to investigate the prevalence and endotypes of INOCA in LCS patients with chest pain. This study will be conducted at Hospital Clínico San Carlos, Madrid, Spain.
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 will be enrolled in this study.
After obtaining patient's informed consent. patients will be randomized by simple randomization in a 1:1 ratio using a central online module to 1) tailored treatment guided by the results of CFT (intervention) or 2) the routine standard of care treatment (sham). All patients will undergo an invasive coronary angiogram as a first step. Patients with severe epicardial coronary artery stenosis define by stenosis ≥ 90% by angiogram will be excluded for further testing. Patients with intermediate coronary artery stenosis will undergo a wire-based physiological assessment of epicardial stenosis. If there is a significant epicardial coronary artery disease defined by fractional flow reserve (FFR) ≤ 0.80 or non-hyperemic pressure ratio (NPHR) ≤ 0.89, the patients will be excluded for further testing. In patients without significant epicardial coronary artery disease, coronary functional testing which include coronary microvascular dysfunction test and Acetylcholine test will be performed. Both tests will be performed in a standard fashion according to the protocol from the guidelines. The results of the 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.
All patients will receive the medications for treatment of INOCA at an out-patient clinic. In intervention group, patient and physician will receive the CFT's results and medications will be prescribed according to patient's type of INOCA and follow with the recommendations in the EAPCI Consensus Document on INOCA and ESC Guidelines. In sham group, patient and physician will be blinded from the CFT's results for 3 months and medications will be prescribed according to physician's decision during this period. After 3 months, the CFT's result will be given to all patients and the treatment will follow with the recommendations from the guideline. Angina symptom and Quality of life in both groups will be assessed by the Seattle Questionnaire of Angina (SAQ), Duke Activity Status Index (DASI) and Euro-Quality of life 5D (EQ-5D) at baseline and each follow up which will occur at 3, and 12 months.
345 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.
This study's planned enrollment of 108 is below the median of 150 across 236 interventional studies indexed under Angina, Stable.
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- 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:
Treatment of INOCA guided by the results of the coronary functional testing during the entire follow up period (12 months)
Diagnostic Test: Coronary functional test
Treatment of INOCA by the routine standard of care for the first 3 months and guided by the results of the coronary functional testing during the rest of the follow up period (9 months)
Diagnostic Test: 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.
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
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).
Time frame: From the date of enrollment to the end of follow up period at 12 months
The prevalence and type of INOCA in LCS patients with chest pain
INOCA can be diagnosed by Functional coronary testing if there is an evidence of vasomotor disorder (Epicardial or microvascular) from acetylcholine test and/or coronary microvascular dysfunction defined by coronary flow reserve less than 2.5 during hyperemia.
Time frame: From the date of enrollment to the last follow up period at 12 months
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Fundacion Investigacion Interhospitalaria Cardiovascular