Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long C… (NCT07559994) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain
Spain108 participantsStarted 2021-09-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people with Long COVID who have new chest pain and a condition called INOCA — where there's reduced blood flow to the heart even without blocked arteries — does my situation actually match that profile, and is INOCA something my care team has considered or tested for in my case?
2The trial compares a 'treatment guided group' to standard care, using a questionnaire about angina symptoms and quality of life to measure results — can you explain what 'treatment guided' actually means here, and whether the approach being tested is something that could already be offered to me outside of this trial?
3Since this trial is active but no longer recruiting new participants, does that mean I can't join, and if so, are there similar studies or emerging approaches for Long COVID-related chest pain that I should know about?
4This trial focuses on non-obstructive coronary artery disease, which can be harder to diagnose than a typical blockage — what tests would I need to find out whether this type of ischemia is actually causing my chest pain, and have I had those tests yet?
5Because this study is listed as Phase NA, meaning it may be more of a diagnostic or management study than a traditional drug trial, what does that mean for how much is already known about the safety of the approach being tested, and how does it compare to what standard care would offer me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: From the date of enrollment to the end of follow up period at 12 months