Clinical trial NCT05618132: ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs
Official title: Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina Pectoris, Variant
Angina Pectoris; Spasm-Induced
Angina Pectoris With Normal Coronary Arteriogram
Keywords: Vasospastic angina
Angina with non-obstructive coronary arteries (ANOCA)
Acetylcholine
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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 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.

Primary outcomes:
measure: The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
timeFrame: Baseline
measure: The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.
timeFrame: Baseline
Secondary outcomes:
measure: The percent of ACH provoked spasm that resolves after IC administration of verapamil.
timeFrame: Baseline
measure: The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.
timeFrame: Baseline
Other outcomes:
measure: Proportion of patients with epicardial coronary artery spasm who have microvascular spasm after either verapamil or verapamil + NTG.
timeFrame: Baseline
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Baseline
measure: Absolute changes in the individual, overall and summary score of the Seattle Angina Questionnaire (SAQ) from baseline to the first ambulatory control visit.
timeFrame: Baseline, 1 month
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Tijs Bringmans
role: PRINCIPAL_INVESTIGATOR
References: