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Recruiting NCT05618132

ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

Conditions: Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Antwerp

Location: Belgium

Summary

The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA).The main questions it aims to answer are:to determine the efficacy of these drugs in treating ACH-induced coronary artery spasmto determine the efficacy of these drugs in preventing ACH-induced coronary artery spasmThe ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.

Eligibility Criteria

Inclusion Criteria:Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR > 0.89) and hyperemic indices (FFR > 0.80).ACH provoked epicardial and/or microvascular spasmLeft ventricular ejection fraction (LVEF) > 50%Renal function with eGFR ≥ 40 ml/minExclusion Criteria:Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular diseaseLVEF < 50%Long QT syndrome (LQTS) - genetic or acquiredVentricular paced rhythmRenal failure with eGFR < 40 ml/minThyroid stimulating hormone (TSH) < lower limit of normal (LLN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in the opinion of the investigator, the subject is in a clinically euthyroid state.Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.Pregnant female subjects. Female subjects of child-bearing potential should be on adequate contraceptive measures or are to be screened with a urine pregnancy test.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05618132). StuddyBuddy aggregates publicly available trial information.