Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03525860
Status:
COMPLETED
Last Update Posted:
2021-11-12
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acupuncture treatment in the hospital setting', 'timeFrame': '3 days post surgery', 'description': 'The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with recurrent atrial fibrillation', 'timeFrame': '3 consecutive days post-surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Operative Atrial Fibrillation', 'Acupuncture Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.', 'detailedDescription': "Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.\n\nSecondary Aims\n\n• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have undergone CABG and/or cardiac valve operations.\n2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.\n3. Patients moving to the step-down unit on postoperative day 2 or later.\n4. Ability to provide informed consent.\n5. Ability to speak English and complete all aspects of this trial.\n6. At least 18 years of age.\n\nExclusion Criteria:\n\n1. Patients with any other cardiac or non-cardiac concomitant procedures.\n2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.\n3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.\n4. Patients with platelet count \\<50,000\n5. Patients in a severe immunocompromised state.\n6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.'}, 'identificationModule': {'nctId': 'NCT03525860', 'briefTitle': 'Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study', 'orgStudyIdInfo': {'id': '17-006095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture Treatment', 'description': '20 subjects will be treated with standard of care and acupuncture.\n\nWill complete Symptom and Pain questionnaire (VAS) and a Was It Worth It (WIWI) questionnaire each day of study participation (3 days).', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': '20 subjects will be treated with standard of care only.\n\nWill complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).'}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.\n\nThe acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.\n\n11 sterile, single use, disposable needles will be placed one by one until all needles are in place.\n\nNeedles remain in place for additional 20 minutes or so as the patient remains in the selected position\n\n.', 'armGroupLabels': ['Acupuncture Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Chaim Leker Locker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}