Mechanocardiography in Patients With STEMI (MECHANO-STEMI)

May 7, 2024 updated by: Juhani Airaksinen, University of Turku

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

- Consecutive patients presenting with ST-segment elevation

Description

Inclusion Criteria:

  • Myocardial ischemia with ST-segment elevation in ECG
  • Primary PCI procedure

Exclusion Criteria:

  • Age >17 years
  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STEMI before PCI
ST-segment elevation, recording acquired before coronary intervention
Diagnostic test: Mechanocardiography
Mechanocardiographic recording
STEMI after PCI
ST-segment elevation, recording acquired from the same patients after coronary intervention
Diagnostic test: Mechanocardiography
Mechanocardiographic recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T02/006/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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