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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasospastic angina | Experimental | Interventional diagnostic protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylcholine rechallenge | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil. | Is verapamil able to suppress ACH-induced coronary artery spasm? | Baseline |
| The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG. | Is verapamil + NTG able to suppress ACH-induced coronary artery spasm? | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of ACH provoked spasm that resolves after IC administration of verapamil. | How efficient is verapamil IC as a treatment for ACH-induced coronary artery spasm? | Baseline |
| The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with epicardial coronary artery spasm who have microvascular spasm after either verapamil or verapamil + NTG. | Do microvascular and epicardial vasospasm occur simultaneously and is it possible to unmask microvascular spasm with either verapamil or verapamil + NTG. | Baseline |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tijs Bringmans | Contact | +32 3 821 3843 | tijs.bringmans@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Tijs Bringmans | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Recruiting | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D000788 | Angina Pectoris, Variant |
| D000787 | Angina Pectoris |
| D017566 | Microvascular Angina |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
How efficient is verapamil and NTG IC as a treatment for ACH-induced coronary artery spasm? |
| Baseline |
Are there safety concerns related to the proposed ACH rechallenge protocol? |
| Baseline |
| Absolute changes in the individual, overall and summary score of the Seattle Angina Questionnaire (SAQ) from baseline to the first ambulatory control visit. | Does treatment based on the current protocol improve control of angina at the first ambulatory visit compared to before the coronary function tests? | Baseline, 1 month |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |