NCT04151966

Brief Summary

Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

November 2, 2019

Last Update Submit

January 4, 2022

Conditions

Cardioversion

Outcome Measures

Primary Outcomes (1)

  • Myocardial injury

    Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

    Baseline, 6-24 hours post procedure

Study Arms (1)

Cardioversion Group

Subjects scheduled to undergo direct current cardioversion (DCCV) as part of the clinical plan of care

Diagnostic Test: Blood sample collection

Interventions

Blood sample collectionDIAGNOSTIC_TEST

Blood sample collection for markers of myocardial injury

Cardioversion Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male and females age 18 and above identified from the electronic medical record (EMR) calendar of patients scheduled for an elective direct current cardioversion.

You may qualify if:

  • Patients who are undergoing elective direct current cardioversion, either externally or via the patient's internal cardioverter-defibrillator

You may not qualify if:

  • Patients under age 18
  • Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
  • Pregnant patients
  • Patients who cannot provide informed consent because of cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum or plasma samples remaining after initial analysis will be frozen and stored at -80 degrees Celsius for 120 months (10 years). These samples may be used if there are new and more sensitive biomarkers of myocardial injury that become available.

Study Officials

  • Allan S Jaffe, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 5, 2019

Study Start

July 22, 2019

Primary Completion

June 5, 2020

Study Completion

December 1, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)