NCT03441724

Brief Summary

The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

7.3 years

First QC Date

February 7, 2018

Last Update Submit

May 7, 2024

Conditions

Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Study Arms (2)

STEMI before PCI

ST-segment elevation, recording acquired before coronary intervention

Diagnostic Test: Mechanocardiography

STEMI after PCI

ST-segment elevation, recording acquired from the same patients after coronary intervention

Diagnostic Test: Mechanocardiography

Interventions

MechanocardiographyDIAGNOSTIC_TEST

Mechanocardiographic recording

STEMI after PCISTEMI before PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Consecutive patients presenting with ST-segment elevation

You may qualify if:

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

You may not qualify if:

  • Age \>17 years
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 22, 2018

Study Start

January 1, 2018

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

FI(1)