Supraventricular TachycardiaNCT02810561
Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
An observational study of Supraventricular Tachycardia, run by Corewell Health South.
Trial summary
The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Supraventricular Tachycardia
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients presenting to the Emergency Department with Supraventricular Tachycardia and elevated troponin. All sexs, races and ages will be included.
Who may be able to join
- Supraventricular Tachycardia with troponin elevation
Who cannot join
- Other cardiac arrhythmias or conditions with increased troponin
About this study
Official title: Time Course and the Significance of Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of stay. Second, given conflicting results in the literature, the investigators would like to determine if elevated troponin levels correlate to later cardiovascular complications. These complications will be defined as Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting or bypass). As the investigator is a single hospital system in this county it is uniquely positioned to be able to review this retrospectively.
Read the detailed description
The investigators therefore propose retrospectively studying participants diagnosed with Supraventricular Tachycardia who had troponin(s) checked in the ED between January 1, 2012 and May 31, 2016 to allow a minimum of a year follow-up for our combined endpoint. The investigators will record the participants troponin value(s) in addition to the age, sex, race, heart rate, creatinine value. The investigators will compare the participants with positive troponins (and hopefully participants with strongly positive troponins) with those who are negative for troponin for presence of the combined end point via chart review.
- Conditions
- Supraventricular Tachycardia
- Being tested
- No Intervention
- Keywords
- Troponin
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention was completed with this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin-I Level
Measured in ng/ml
Measured: 6 hours after initial EKG
Secondary outcomes (1)
Death/ Need for Cardiac Stent Placement or Coronary Bypass Artery Graft
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJan 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Hysell, MD, Principal investigator, Lakeland Health Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810561
- Sponsor's protocol ID
- LH01
- Status last verified
- Aug 2022
- First submitted
- 26 Apr 2016
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course and the Significance of Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
- ClinicalTrials.gov ID
- NCT02810561
- Acronym / sponsor ID
- LH01
- Conditions
- Supraventricular Tachycardia
- Keywords
- Troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of stay. Second, given conflicting results in the literature, the investigators would like to determine if elevated troponin levels correlate to later cardiovascular complications. These complications will be defined as Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting or bypass). As the investigator is a single hospital system in this county it is uniquely positioned to be able to review this retrospectively.
Detailed description
The investigators therefore propose retrospectively studying participants diagnosed with Supraventricular Tachycardia who had troponin(s) checked in the ED between January 1, 2012 and May 31, 2016 to allow a minimum of a year follow-up for our combined endpoint. The investigators will record the participants troponin value(s) in addition to the age, sex, race, heart rate, creatinine value. The investigators will compare the participants with positive troponins (and hopefully participants with strongly positive troponins) with those who are negative for troponin for presence of the combined end point via chart review.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting to the Emergency Department with Supraventricular Tachycardia and elevated troponin. All sexs, races and ages will be included.
Key inclusion criteria (1 listed)
- Supraventricular Tachycardia with troponin elevation
Key exclusion criteria (1 listed)
- Other cardiac arrhythmias or conditions with increased troponin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention was completed with this study. | Other | – |
Primary outcome
Troponin-I Level
Time frame: 6 hours after initial EKG
Measured in ng/ml
1 secondary outcome
Death/ Need for Cardiac Stent Placement or Coronary Bypass Artery Graft
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hysell, MD principal investigator
Lakeland Health Emergency Department
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Tachycardia, run by Corewell Health South.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin-I Level (time frame: 6 hours after initial EKG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.