ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs
NCT ID: NCT05618132
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-01-09
2024-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Vasospastic angina
Interventional diagnostic protocol
Acetylcholine rechallenge
STEP 1 consists of verapamil 1mg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is given (step 2). If verapamil suppresses spasm, ACH rechallenge (ACHR) is performed after 3 minutes.
In STEP 2, patients with persistent spasm after verapamil or with spasm after ACHR receive NTG 200µg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is delivered again. If refractory spasm occurs, atropine 1mg IV is given. Coronary spasm is considered suppressed once ACHR can no longer provoke spasm. NTG 200µg IC is given as final drug regardless of spasm.
ACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm).
Interventions
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Acetylcholine rechallenge
STEP 1 consists of verapamil 1mg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is given (step 2). If verapamil suppresses spasm, ACH rechallenge (ACHR) is performed after 3 minutes.
In STEP 2, patients with persistent spasm after verapamil or with spasm after ACHR receive NTG 200µg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is delivered again. If refractory spasm occurs, atropine 1mg IV is given. Coronary spasm is considered suppressed once ACHR can no longer provoke spasm. NTG 200µg IC is given as final drug regardless of spasm.
ACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Principal Investigators
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Tijs Bringmans
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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University Hospital Antwerp
Antwerp, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2806
Identifier Type: -
Identifier Source: org_study_id
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