NCT07097168

Brief Summary

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:

  • Can changes in HRV, measured by the WHOOP device, help predict how well patients with CAD will recover after CABG surgery?
  • Can HRV changes during the hospital stay give doctors useful information about the patient's recovery? Participants will:
  • Wear the WHOOP device before and after their CABG surgery to measure HRV.
  • Share their health information to help researchers see how changes in HRV are connected to recovery. This 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2026

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

May 28, 2025

Last Update Submit

July 30, 2025

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass GraftCABGHeart SurgeryHeart DiseaseCoronary Artery DiseaseWHOOPHRVHeart Rate Variability

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Rate Variability (HRV) Before and After CABG Surgery

    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.

    - 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.

Secondary Outcomes (1)

  • Understanding correlation in HRV measurements taken immediately after surgery compared versus HRV measurements taken prior to hospital discharge.

    Two HRV measurements taken for comparison; - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Years or older
  • Coronary Artery Disease diagnosis
  • Must be scheduled for isolated Coronary Artery Bypass Surgery

You may not qualify if:

  • Acute heart failure
  • Acute coronary syndrome (e.g. heart attack/myocardial infarction) in the last 3 months.
  • Prior history of heart transplant
  • Cardiac assist device (e.g., ventricular assist device, balloon pump)
  • Current pacemaker
  • Congenital heart disease
  • Currently admitted and undergoing treatment for cardiac issues e.g., inotropes, etc,
  • Atrial fibrillation
  • Frequent premature ventricular complex
  • Sinus node dysfunction
  • Second and third-degree atrioventricular block
  • Combined cardiac surgeries
  • Unable to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (9)

  • 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: 34065516BACKGROUND

  • 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: 33390146BACKGROUND

  • 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: 19936115BACKGROUND

  • 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: 35535246BACKGROUND

  • 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: 16630090BACKGROUND

  • 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: 36016077BACKGROUND

  • 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: 33941604BACKGROUND

  • 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: 2404169BACKGROUND

  • 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.

    PMID: 30790284BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Frederick C Cobey, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 31, 2025

Study Start

June 11, 2025

Primary Completion

January 11, 2026

Study Completion

March 11, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

US(1)