Myocardial Oxygenation ImbalanceCOMINGNCT03953651
Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
An observational study of Myocardial Oxygenation Imbalance and Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Oxygenation Imbalance, Myocardial Infarction
- What is being tested?
- Follow-up
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2019to 9 Jul 2020
- 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: Male or female patients at least 18 years old admitted to the emergency department with a myocardial oxygenation imbalance
Who may be able to join
- age 18 years old or older ;
- At least one condition of myocardial oxygenation imbalance :
- Oxygen saturation below 90% ;
- Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ;
- Persistent heart rate over 110 beats per minute, for more than 20 minutes ;
- Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ;
- Persistent systolic blood pressure over 180 mmHg for more than 20 minutes.
Who cannot join
- Patient admitted with type 1 myocardial infarction ;
- Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc…)
- Patient who declines to participate;
- Pregnant or breastfeeding women ;
- Patient deprived of liberty (inmate, administrative protection)
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.
The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.
- Being tested
- Follow-up
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients admitted in the emergency department presenting a myocardial oxygenation imbalance and are therefore at risk for Myocardial Infarction (MI) type 2. Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of a Major Adverse Cardiovascular Event at 6 months
Onset of a Major Adverse Cardiovascular Event such as:
- Cardiovascular death
- Non fatal myocardial infarction
- Admission for acute heart failure
- Non fatal stroke
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 posted16 May 2019
- Study start10 Jul 2019
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Oxygenation ImbalanceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent JACQUIN, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953651
- Sponsor's protocol ID
- 69HCL18_0913
- Other IDs
- 2019-A00177-50
- Acronym
- COMING
- Status last verified
- Jul 2020
- First submitted
- 15 May 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
- ClinicalTrials.gov ID
- NCT03953651
- Acronym / sponsor ID
- COMING / 69HCL18_0913
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.
The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Follow-upPatients admitted in the emergency department presenting a myocardial oxygenation imbalance and are therefore at risk for Myocardial Infarction (MI) type 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients at least 18 years old admitted to the emergency department with a myocardial oxygenation imbalance
Key inclusion criteria (7 listed)
- age 18 years old or older ;
- At least one condition of myocardial oxygenation imbalance :
Key exclusion criteria (5 listed)
- Patient admitted with type 1 myocardial infarction ;
- Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc…)
- Patient who declines to participate;
- Pregnant or breastfeeding women ;
- Patient deprived of liberty (inmate, administrative protection)
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 |
|---|---|---|
| Follow-upOnset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion. | Other | Patients |
Primary outcome
Onset of a Major Adverse Cardiovascular Event at 6 months
Time frame: 6 months
Onset of a Major Adverse Cardiovascular Event such as: * Cardiovascular death * Non fatal myocardial infarction * Admission for acute heart failure * Non fatal stroke
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 28 Jul 2020.
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.
Laurent JACQUIN, Dr principal investigator
Hospices Civils de Lyon
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 Myocardial Oxygenation Imbalance and Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 5 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 28 Jul 2020. 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 France. 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?
Onset of a Major Adverse Cardiovascular Event at 6 months (time frame: 6 months). 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 28 Jul 2020.