Acute Coronary SyndromeNCT02959788
Heart Rate Variability as a Predictor of Ischemic Heart Disease
An observational study of Acute Coronary Syndrome, run by University of Iowa at 1 site in United States.
Trial summary
Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Heart rate variability
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults who present to the emergency department with chest pain.
Who may be able to join
- Chest pain in ED
Who cannot join
- STEMI
- Prisoners
- Pregnant women
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.
Read the detailed description
Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.
The investigators propose to enroll patients admitted to the emergency department with chest pain. In addition to HRV data, clinical risk factors will be obtained, using validated clinical risk scoring systems. The team will follow patient's clinical course in order to include information about the determined cause of chest pain. The goal is to understand how HRV can augment common risk stratification scoring systems for patient presenting to the ED with chest pain.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Heart rate variability
- Keywords
- Heart rate variability
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variabilityOther
All patients have a 10-minute recording analyzed for indices of heart rate variability.
| Study group | Role | What they receive |
|---|---|---|
| Chest pain patients | All patients who present to the ED with chest pain. Receives: Other: Heart rate variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: 30 days
Secondary outcomes (2)
HEART score
Measured: 1 day
Coronary heart disease risk factors
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohr, Nicholas M, University of Iowa
- Investigators
- Nicholas M Mohr, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959788
- Sponsor's protocol ID
- 201512751
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability as a Predictor of Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT02959788
- Acronym / sponsor ID
- 201512751
- Conditions
- Acute Coronary Syndrome
- Keywords
- Heart rate variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Nov 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.
Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.
Detailed description
Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.
The investigators propose to enroll patients admitted to the emergency department with chest pain. In addition to HRV data, clinical risk factors will be obtained, using validated clinical risk scoring systems. The team will follow patient's clinical course in order to include information about the determined cause of chest pain. The goal is to understand how HRV can augment common risk stratification scoring systems for patient presenting to the ED with chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest pain patients | – | Other: Heart rate variabilityAll patients who present to the ED with chest pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults who present to the emergency department with chest pain.
Key inclusion criteria (1 listed)
- Chest pain in ED
Key exclusion criteria (4 listed)
- STEMI
- Prisoners
- Pregnant women
- Unable to consent
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 |
|---|---|---|
| Heart rate variabilityAll patients have a 10-minute recording analyzed for indices of heart rate variability. | Other | Chest pain patients |
Primary outcome
Major adverse cardiac events
Time frame: 30 days
2 secondary outcomes
HEART score
Time frame: 1 day
Coronary heart disease risk factors
Time frame: 1 day
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 14 Feb 2017.
- Individual participant dataSharing planned: No
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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AI-Assisted Interpretation of Cardiac CT in the Emergency Department
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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Nicholas M Mohr, MD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University of Iowa at 1 site in United States.
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 4 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 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Major adverse cardiac events (time frame: 30 days). 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 14 Feb 2017.