ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

Not Applicable

Recruiting

• Conditions: Angina Pectoris; Spasm-Induced; Angina Pectoris With Normal Coronary Arteriogram; Angina Pectoris, Variant
• Interventions: Diagnostic Test: Acetylcholine rechallenge

• Registration Number: NCT05618132
• Lead Sponsor: University Hospital, Antwerp

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-16
• Study Start: 2023-01-09
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vasospastic angina	Acetylcholine rechallenge	Interventional diagnostic protocol

Primary Outcome Measures

Name	Time	Method
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.	Baseline	Is verapamil able to suppress ACH-induced coronary artery spasm?
The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.	Baseline	Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?

Secondary Outcome Measures

Name	Time	Method
The percent of ACH provoked spasm that resolves after IC administration of verapamil.	Baseline	How efficient is verapamil IC as a treatment for ACH-induced coronary artery spasm?
The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.	Baseline	How efficient is verapamil and NTG IC as a treatment for ACH-induced coronary artery spasm?

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium