U.S. flag

An official website of the United States government

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Coeytaux RR, Leisy PJ, Wagner GS, et al. Systematic Review of ECG-based Signal Analysis Technologies for Evaluating Patients With Acute Coronary Syndrome [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jun.

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Systematic Review of ECG-based Signal Analysis Technologies for Evaluating Patients With Acute Coronary Syndrome

Systematic Review of ECG-based Signal Analysis Technologies for Evaluating Patients With Acute Coronary Syndrome [Internet].

Show details

Appendix CInclusion and Exclusion Criteria

Table C-1Summary of inclusion and exclusion criteria

Study CharacteristicInclusion CriteriaExclusion Criteria
Population
  • Symptomatic patients at low to intermediate risk (“symptomatic” defined as any symptom that gives the diagnosing physician suspicion of ACS/CAD/ischemia)
  • Population can include both symptomatic and asymptomatic patients if data for symptomatic patients were reported separately
  • Population can include both high-risk and low-to-intermediate risk patients if data for low-to-intermediate risk patients were reported separately
  • Patients all ≥18 years of age, or if some patients <18, data for patients ≥18 must be presented separately
  • Study addresses only asymptomatic or high-risk patients
  • Sample size <20 patients
Devices
  • Obtains and interprets electrical activity from the heart (ECG-based)
  • Utilizes standard 12-lead information or has additional leads (e.g., body surface mapping)
  • Transforms/interprets electrical signal in a novel way. Data transformation into spatial imaging or through advanced mathematics (e.g., Fast Fourier Transform) to produce new indexes that are relevant
  • Claimed to be useful for diagnosing CAD, ACS, or detecting myocardial ischemia
  • Commercially available in the United States
  • Has received FDA approval or clearance for marketing
  • Purpose of device use in the study is only to detect arrhythmias.
  • Does not address diagnosing CAD, ischemia, or ACS
Outcomes
  • Performance characteristics of the device
  • Effects on diagnostic or treatment decisions
  • Effects on patient outcomes of interest:
    • catheterization laboratory findings
    • clinical outcomes of mortality
    • cardiac symptoms
    • function and functional status
    • therapeutic interventions
None
Setting
  • Implementation of the device in most medical facilities must be feasible
  • Studies that occur in the catheterization laboratory may be included if all other criteria are met
Implementation of the device requires facilities that are not typically available in most medical facilities in the United States
Publications
  • English language articles
  • Peer-reviewed, full-length publication of original data (relevant followup studies and subgroup analyses meet criteria for inclusion)
  • Articles not published in English, or not peer-reviewed
  • Not original data (e.g., editorials, letters to the editor, opinion pieces). Systematic reviews and meta-analyses were excluded from abstraction but were hand-searched as potential sources of additional material if relevant to the topic.

Abbreviations: ACS=acute coronary syndrome; CAD=coronary artery disease; ECG=electrocardiogram; FDA=U.S. Food and Drug Administration

Views

  • PubReader
  • Print View
  • Cite this Page
  • PDF version of this title (685K)

Other titles in these collections

Recent Activity

ClearTurn OffTurn On

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...