Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 8:37 PM
Study NCT ID:
NCT05618132
Status:
UNKNOWN
Last Update Posted:
2023-01-19
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000788', 'term': 'Angina Pectoris, Variant'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients with epicardial coronary artery spasm who have microvascular spasm after either verapamil or verapamil + NTG.', 'timeFrame': 'Baseline', 'description': 'Do microvascular and epicardial vasospasm occur simultaneously and is it possible to unmask microvascular spasm with either verapamil or verapamil + NTG.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Baseline', 'description': 'Are there safety concerns related to the proposed ACH rechallenge protocol?'}, {'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', 'description': 'Does treatment based on the current protocol improve control of angina at the first ambulatory visit compared to before the coronary function tests?'}], 'primaryOutcomes': [{'measure': 'The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.', 'timeFrame': 'Baseline', 'description': 'Is verapamil able to suppress ACH-induced coronary artery spasm?'}, {'measure': 'The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.', 'timeFrame': 'Baseline', 'description': 'Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?'}], 'secondaryOutcomes': [{'measure': 'The percent of ACH provoked spasm that resolves after IC administration of verapamil.', 'timeFrame': 'Baseline', 'description': 'How efficient is verapamil IC as a treatment for ACH-induced coronary artery spasm?'}, {'measure': 'The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.', 'timeFrame': 'Baseline', 'description': 'How efficient is verapamil and NTG IC as a treatment for ACH-induced coronary artery spasm?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vasospastic angina', 'Angina with non-obstructive coronary arteries (ANOCA)', 'Acetylcholine'], 'conditions': ['Angina Pectoris, Variant', 'Angina Pectoris; Spasm-Induced', 'Angina Pectoris With Normal Coronary Arteriogram']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\n* to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm\n* to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)\n* 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).\n* ACH provoked epicardial and/or microvascular spasm\n* Left ventricular ejection fraction (LVEF) \\> 50%\n* Renal function with eGFR ≥ 40 ml/min\n\nExclusion Criteria:\n\n* Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)\n* Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease\n* LVEF \\< 50%\n* Long QT syndrome (LQTS) - genetic or acquired\n* Ventricular paced rhythm\n* Renal failure with eGFR \\< 40 ml/min\n* 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.\n* Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.\n* 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.'}, 'identificationModule': {'nctId': 'NCT05618132', 'acronym': 'ReACHallenge', 'briefTitle': 'ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment', 'orgStudyIdInfo': {'id': '2806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vasospastic angina', 'description': 'Interventional diagnostic protocol', 'interventionNames': ['Diagnostic Test: Acetylcholine rechallenge']}], 'interventions': [{'name': 'Acetylcholine rechallenge', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nIn 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.\n\nACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm).', 'armGroupLabels': ['Vasospastic angina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tijs Bringmans', 'role': 'CONTACT', 'email': 'tijs.bringmans@uza.be'}, {'name': 'Vincent FM Segers', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'centralContacts': [{'name': 'Tijs Bringmans', 'role': 'CONTACT', 'email': 'tijs.bringmans@uza.be', 'phone': '+32 3 821 3843'}], 'overallOfficials': [{'name': 'Tijs Bringmans', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}