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ACTIVE NOT RECRUITING
NCT07559994
NA

Microvascular Dysfunction in Patients With Long-Covid Syndrome and Angina

Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular

View on ClinicalTrials.gov

Summary

Long-Covid 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 type of ischemia with non-obstructive coronary arteries (INOCA) in patients with LCS and 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 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, 6, and 12 months using the Seattle Questionnaire of Angina (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.

Official title: Microvascular Dysfunction in Patients With Long-Covid Syndrome and Angina: the Long-Covid INOCA Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2021-09-02

Completion Date

2026-06-30

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hospital Clinico San Carlos

Madrid, Madrid, Spain