NCT01150825

Brief Summary

The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 8, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

June 10, 2010

Last Update Submit

February 6, 2011

Conditions

Keywords

STEMINSTEMIacute ischemianon-invasive diagnosiselevated troponin

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Acute Myocardial Infarction

    The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.

    Prior to hospitalization release

Secondary Outcomes (1)

  • HFQRS analysis for detecting NSTEMI

    Post data processing

Study Arms (2)

STEMI

Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels

NSTEMI

Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting with confirmed AMI in the intensive cardiac care unit (ICCU) of Soroka Medical Center (Beer Sheva, Israel), who are expected to undergo percutaneous coronary intervention (PCI) will be asked to participate in the study. These include both ST-elevation MI (STEMI) and non ST-elevation MI (NSTEMI) patients, with positive biomarkers and clear ongoing electrocardiographic or clinical evidence of ischemia.

You may qualify if:

  • Age \> 40 years (men and women)
  • Time from onset of chest pain ≤ 12h
  • AMI confirmed by biomarkers
  • Clinical or electrocardiographic evidence of ischemia during recording
  • Signed an informed consent

You may not qualify if:

  • Prior MI
  • Prior CABG
  • pre-excitation syndrome (e.g. WP)
  • Atrial Fibrillation or significant ventricular arrhythmia
  • BBB, intraventricular conduction delay or QRS duration \> 120 ms
  • Implanted pacemaker or defibrillator
  • Left-ventricular hypertrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

Related Publications (1)

  • Amit G, Galante O, Davrath LR, Luria O, Abboud S, Zahger D. High-frequency QRS analysis in patients with acute myocardial infarction: a preliminary study. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):149-56. doi: 10.1111/anec.12023. Epub 2012 Nov 22.

Related Links

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Doron Zahger, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doron Zahger, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 25, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 8, 2011

Record last verified: 2011-02

Locations