Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 8:51 PM
Study NCT ID:
NCT07097168
Status:
WITHDRAWN
Last Update Posted:
2025-07-31
First Post:
2025-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Changes to study staffing and lack of coordinator support.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-06-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heart Rate Variability (HRV) Before and After CABG Surgery', 'timeFrame': '- Pre-operative, Up to 1 hour before surgery (Measurement taken in the pre-op area) - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.', 'description': 'The primary goal of this study is to assess how heart rate variability (HRV) changes in patients with coronary artery disease (CAD) before and after coronary artery bypass graft (CABG) surgery.'}], 'secondaryOutcomes': [{'measure': 'Understanding correlation in HRV measurements taken immediately after surgery compared versus HRV measurements taken prior to hospital discharge.', 'timeFrame': 'Two HRV measurements taken for comparison; - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.', 'description': "The secondary aim of this study would be to associate this change in HRV with the patient's clinical course to establish HRV as a way to assess current patient status and to predict clinical course and outcomes."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Graft', 'CABG', 'Heart Surgery', 'Heart Disease', 'Coronary Artery Disease', 'WHOOP', 'HRV', 'Heart Rate Variability'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34065516', 'type': 'BACKGROUND', 'citation': 'Bellenger CR, Miller DJ, Halson SL, Roach GD, Sargent C. Wrist-Based Photoplethysmography Assessment of Heart Rate and Heart Rate Variability: Validation of WHOOP. Sensors (Basel). 2021 May 20;21(10):3571. doi: 10.3390/s21103571.'}, {'pmid': '33390146', 'type': 'BACKGROUND', 'citation': 'Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.'}, {'pmid': '19936115', 'type': 'BACKGROUND', 'citation': 'Lakusic N, Slivnjak V, Baborski F, Cerovec D. Heart Rate Variability after Off-Pump versus On-Pump Coronary Artery Bypass Graft Surgery. Cardiol Res Pract. 2009;2009:295376. doi: 10.4061/2009/295376. Epub 2009 Sep 1.'}, {'pmid': '35535246', 'type': 'BACKGROUND', 'citation': 'Van Thanh N, Hien NS, Son PN, Son PT. Pattern Changes in the Heart Rate Variability of Patients Undergoing Coronary Artery Bypass Grafting Surgery. Cardiol Res Pract. 2022 Apr 30;2022:1455025. doi: 10.1155/2022/1455025. eCollection 2022.'}, {'pmid': '16630090', 'type': 'BACKGROUND', 'citation': 'Evrengul H, Tanriverdi H, Kose S, Amasyali B, Kilic A, Celik T, Turhan H. The relationship between heart rate recovery and heart rate variability in coronary artery disease. Ann Noninvasive Electrocardiol. 2006 Apr;11(2):154-62. doi: 10.1111/j.1542-474X.2006.00097.x.'}, {'pmid': '36016077', 'type': 'BACKGROUND', 'citation': 'Miller DJ, Sargent C, Roach GD. A Validation of Six Wearable Devices for Estimating Sleep, Heart Rate and Heart Rate Variability in Healthy Adults. Sensors (Basel). 2022 Aug 22;22(16):6317. doi: 10.3390/s22166317.'}, {'pmid': '33941604', 'type': 'BACKGROUND', 'citation': 'Dimeling G, Bakaeen L, Khatri J, Bakaeen FG. CABG: When, why, and how? Cleve Clin J Med. 2021 May 3;88(5):295-303. doi: 10.3949/ccjm.88a.20115.'}, {'pmid': '2404169', 'type': 'BACKGROUND', 'citation': 'Cromwell J, Mitchell JB, Stason WB. Learning by doing in CABG surgery. Med Care. 1990 Jan;28(1):6-18. doi: 10.1097/00005650-199001000-00003.'}, {'pmid': '30790284', 'type': 'BACKGROUND', 'citation': 'Malakar AK, Choudhury D, Halder B, Paul P, Uddin A, Chakraborty S. A review on coronary artery disease, its risk factors, and therapeutics. J Cell Physiol. 2019 Aug;234(10):16812-16823. doi: 10.1002/jcp.28350. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to use the WHOOP device to measure heart rate variability (HRV) in patients with coronary artery disease (CAD) before and after they have CABG (coronary artery bypass graft) surgery. The main questions it aims to answer are:\n\n* Can changes in HRV, measured by the WHOOP device, help predict how well patients with CAD will recover after CABG surgery?\n* Can HRV changes during the hospital stay give doctors useful information about the patient's recovery?\n\nParticipants will:\n\n* Wear the WHOOP device before and after their CABG surgery to measure HRV.\n* Share their health information to help researchers see how changes in HRV are connected to recovery.\n\nThis study will help find out if the WHOOP device can be used as a medical tool to track recovery in patients with CAD after CABG surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants for validation will come from the general population and will be allowed to come forward to the study team to express interest. Study team members will place flyers in public areas (e.g., waiting rooms) throughout the Tufts Medical Center campus. Flyers will contain contact information of the study team as well as a QR Code to a screening form for participants to fill out if they are interested in participating.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 Years or older\n* Coronary Artery Disease diagnosis\n* Must be scheduled for isolated Coronary Artery Bypass Surgery\n\nExclusion Criteria: Participants will be excluded if they have the following;\n\n* Acute heart failure\n* Acute coronary syndrome (e.g. heart attack/myocardial infarction) in the last 3 months.\n* Prior history of heart transplant\n* Cardiac assist device (e.g., ventricular assist device, balloon pump)\n* Current pacemaker\n* Congenital heart disease\n* Currently admitted and undergoing treatment for cardiac issues e.g., inotropes, etc,\n* Atrial fibrillation\n* Frequent premature ventricular complex\n* Sinus node dysfunction\n* Second and third-degree atrioventricular block\n* Combined cardiac surgeries\n* Unable to consent.'}, 'identificationModule': {'nctId': 'NCT07097168', 'briefTitle': 'Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Evaluating Clinical Course in Coronary Artery Bypass Patients Using the WHOOP Fitness Band Heart Rate Variability Application.', 'orgStudyIdInfo': {'id': 'STUDY00004109'}}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Frederick C Cobey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'We plan to share all collected IPD, including demographic information, clinical measurements, and outcomes data (e.g., heart rate variability, recovery progress, and post-surgery health status). This data will be available for researchers who request it, in accordance with a data-sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}