A Novel Method for Enhancement of Standard Rest Electrocardiograms (ECG) Provides New Parameters for Early Detection of Coronary Artery Disease (CAD)

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01909817
• Other study ID #: HYMC-9-2003
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2013
• Last updated: July 24, 2013
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The investigators aim to determine whether a new method of enhancing and improving ECG acquisition, analysis and display is effective. The investigators will perform superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal alignment to the peak R wave and voltage alignment to an improved baseline at the T-P segment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing routine coronary angiogram

Exclusion Criteria:

• Patients with significant irregular heart rhythm

• Patients with heart failure

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• Routine coronary angiogram

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG Voltage spread	We will measure the voltage spread at the S-T and P-R intervals after superimposition and summation of multiple standard ECG cycles in the same lead, by temporal alignment to the peak R wave and voltage alignment to an improved baseline at the T-P segment.	One month	No