Acute Coronary SyndromeNCT02699788
Emergency Department MCG for Suspected Acute Coronary Syndrome
A study testing Multifunction Cardiogram in people with Acute Coronary Syndrome, run by Tampa General Hospital at 1 site in United States.
Trial summary
The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. 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?
- Multifunction Cardiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 29 Nov 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 and over.
- Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician.
- Has an electrocardiogram performed while in the ED.
Who cannot join
- Acute ST-segment elevation MI.
- Patient unable or unwilling to complete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Multifunction Cardiogram
- 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.
Multifunction CardiogramDevice
| Study group | Role | What they receive |
|---|---|---|
| Multifunction Cardiogram | Experimental | non-invasive computerized, multiphase, resting electrocardiogram analysis device Receives: Device: Multifunction Cardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).
MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization.
2.2 Seco11dary
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017
- Study completion29 Nov 2017
Why it stopped: No patients enrolled, sponsor refused to pay site invoices.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Wilson, MD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699788
- Sponsor's protocol ID
- TGH0006
- Status last verified
- Sep 2019
- First submitted
- 1 Feb 2016
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department MCG for Suspected Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02699788
- Acronym / sponsor ID
- TGH0006
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled, sponsor refused to pay site invoices.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 4 Mar 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 to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifunction Cardiogram | Experimental | Device: Multifunction Cardiogramnon-invasive computerized, multiphase, resting electrocardiogram analysis device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and over.
- Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician.
- Has an electrocardiogram performed while in the ED.
Key exclusion criteria (2 listed)
- Acute ST-segment elevation MI.
- Patient unable or unwilling to complete follow-up.
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 |
|---|---|---|
| Multifunction Cardiogram | Device | Multifunction Cardiogram |
Primary outcome
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).
Time frame: 30 days
MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization. 2.2 Seco11dary
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Jason Wilson, MD principal investigator
Tampa General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifunction Cardiogram in people with Acute Coronary Syndrome, run by Tampa General Hospital 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 11 Sep 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE). (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 11 Sep 2019.