Myocardial Infarction, AcuteMECHANO-STEMINCT03441724
Mechanocardiography in Patients With STEMI
An observational study of Myocardial Infarction, Acute, run by University of Turku at 1 site in Finland.
Trial summary
The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Mechanocardiography
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2018to 1 Apr 2025
- 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: - Consecutive patients presenting with ST-segment elevation
Who may be able to join
- Myocardial ischemia with ST-segment elevation in ECG
- Primary PCI procedure
Who cannot join
- Age >17 years
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanocardiographic Detection of Acute ST-Segment Elevation Myocardial Infarction - the MECHANO-STEMI Study
The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.
Read the detailed description
Subsequent patients with ST-segment elevation assigned to the Turku University Hospital Heart Center cathlab for primary percutaneous coronary intervention are enrolled in the study. A 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. A control recording is collected after the coronary intervention, within 24 hours. These recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Mechanocardiography
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MechanocardiographyDiagnostic test
Mechanocardiographic recording
| Study group | Role | What they receive |
|---|---|---|
| STEMI before PCI | ST-segment elevation, recording acquired before coronary intervention Receives: Diagnostic Test: Mechanocardiography | |
| STEMI after PCI | ST-segment elevation, recording acquired from the same patients after coronary intervention Receives: Diagnostic Test: Mechanocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed difference in mechanocardiographic signal
In this novel method for recording cardiac mechanics, we anticipate to observe a difference in machanocardiography signal between the two states - before and after an occlusion of a coronary artery. As of yet, the precise nature of the signal change is unclear and will be clarified as the recorded signals are analyzed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jan 2018
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441724
- Sponsor's protocol ID
- T02/006/15
- Acronym
- MECHANO-STEMI
- Status last verified
- May 2024
- First submitted
- 7 Feb 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanocardiographic Detection of Acute ST-Segment Elevation Myocardial Infarction - the MECHANO-STEMI Study
- ClinicalTrials.gov ID
- NCT03441724
- Acronym / sponsor ID
- MECHANO-STEMI / T02/006/15
- Conditions
- Myocardial Infarction, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Feb 2018 (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.
The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.
Detailed description
Subsequent patients with ST-segment elevation assigned to the Turku University Hospital Heart Center cathlab for primary percutaneous coronary intervention are enrolled in the study. A 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. A control recording is collected after the coronary intervention, within 24 hours. These recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI before PCI | – | Diagnostic Test: MechanocardiographyST-segment elevation, recording acquired before coronary intervention |
| STEMI after PCI | – | Diagnostic Test: MechanocardiographyST-segment elevation, recording acquired from the same patients after coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Consecutive patients presenting with ST-segment elevation
Key inclusion criteria (2 listed)
- Myocardial ischemia with ST-segment elevation in ECG
- Primary PCI procedure
Key exclusion criteria (2 listed)
- Age >17 years
- No informed 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 |
|---|---|---|
| MechanocardiographyMechanocardiographic recording | Diagnostic test | STEMI after PCI, STEMI before PCI |
Primary outcome
Observed difference in mechanocardiographic signal
Time frame: 24 hours
In this novel method for recording cardiac mechanics, we anticipate to observe a difference in machanocardiography signal between the two states - before and after an occlusion of a coronary artery. As of yet, the precise nature of the signal change is unclear and will be clarified as the recorded signals are analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Infarction, Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infarction, Acute, run by University of Turku at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Finland. 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?
Results are not available in the source record.
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?
Observed difference in mechanocardiographic signal (time frame: 24 hours). 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 8 May 2024.