STRess Assessment of INterventional Cardiology Fellows and Attendings

August 31, 2026 updated by: Minneapolis Heart Institute Foundation
Interventional cardiology (IC) fellows and attendings experience high levels of stress. In a recent study, IC fellowship was considered very stressful by 22%, somewhat stressful by 62%, and not stressful by 16%(1). In a different study, 29% of the IC fellows considered leaving their job during the past year, while more than a quarter (29%) felt overwhelmed ≥3x/week(2). Moreover, the same study reports that burnout affects 69% of the interventional cardiologists. In addition, in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2023, 43% of the cardiologists in general reported being burned out and 23% were depressed(3). However, it remains unknown whether they deal with increased stress before, during, and after a procedure, if their stress decreases (and if so, how much) with experience, and how they recover after a procedure. The present study will study the stress levels of IC fellows and attendings using various subjective metrics and wearable devices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The target study population is all interventional cardiology attendings and fellows at Minneapolis Heart Institute.

Description

Inclusion Criteria:

  1. Interventional Cardiology fellow or attending.
  2. Age 18 years or older.
  3. Willing and able to provide informed consent.
  4. Access to smartphone (Apple or Android platform).
  5. Willing and able to wear the wearable devices.

Exclusion Criteria:

1- Any health condition that in the opinion of the investigator would preclude individual's participation in the study such as conditions that would preclude them from wearing the study wearables and participating to provide wearable data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate Variability (HRV)
Time Frame: From enrollment to end of study period at 14 days
Heart Rate Variability (HRV) as assessed by the wearable devices
From enrollment to end of study period at 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: Baseline and at the end of study period at 14 days
Subjective stress assessed by the STAI-short version at baseline, before and after a procedure. Higher scores on the STAI indicate greater anxiety
Baseline and at the end of study period at 14 days
Procedural characteristics
Time Frame: Perioperative
Procedural characteristics as assessed by the post-procedural questionnaire
Perioperative
Burnout
Time Frame: From enrollment to end of study period at 14 days
Burnout as assessed by the Mini-Z survey. A higher score indicates increased burnout
From enrollment to end of study period at 14 days
Heart Rate
Time Frame: From enrollment to end of study period at 14 days
Heart rate as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Sleep
Time Frame: From enrollment to end of study period at 14 days
Sleep metrics as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Blood oxygen
Time Frame: From enrollment to end of study period at 14 days
Blood oxygen as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Respiratory rate
Time Frame: From enrollment to end of study period at 14 days
Respiratory rate as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Body temperature
Time Frame: From enrollment to end of study period at 14 days
Body temperature as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Workout metrics
Time Frame: From enrollment to end of study period at 14 days
Workout metrics as assessed by the wearable device(s).
From enrollment to end of study period at 14 days
Energy consumption
Time Frame: From enrollment to end of study period at 14 days
Energy consumption as assessed by the wearable device(s).
From enrollment to end of study period at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Minneapolis Heart Institute Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STRAIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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