ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

Antwerp University Hospital (UZA)

Status

Enrolling

Conditions

Angina Pectoris With Normal Coronary Arteriogram

Angina Pectoris; Spasm-Induced

Angina Pectoris, Variant

Treatments

Diagnostic Test: Acetylcholine rechallenge

Study type

Interventional

Funder types

Other

Identifiers

NCT05618132

2806

Details and patient eligibility

About

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 spasm
to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm

The 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 spasm
Left ventricular ejection fraction (LVEF) > 50%
Renal function with eGFR ≥ 40 ml/min

Exclusion criteria

Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
LVEF < 50%
Long QT syndrome (LQTS) - genetic or acquired
Ventricular paced rhythm
Renal failure with eGFR < 40 ml/min
Thyroid 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.