Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Angina Pectoris, Variant
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
Time Frame: 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.
Time Frame: Baseline
Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?
Secondary Outcomes
- The percent of ACH provoked spasm that resolves after IC administration of verapamil.(Baseline)
- The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.(Baseline)