Ignite Creation Date:
2024-05-05 @ 10:43 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01174797
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2010-08-02
Brief Title:
Evaluation of Microvolt T-Wave AlternansMTWA Testing for the Detection of Active Ischemia
Sponsor:
Cambridge Heart Inc
Organization:
Cambridge Heart Inc
Study Overview
Official Title:
Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients With Known or Suspected Coronary Artery Disease A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTWA-CAD
Brief Summary:
MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans MTWA testing for the purpose of detecting active ischemia in patients with known or suspected coronary artery disease CAD MTWA is a subtle alternating pattern in the T wave portion of the surface electrocardiogram ECG that is associated with increased risk of ventricular tachyarrhythmias and sudden cardiac arrest SCA
Detailed Description:
Ischemia a common trigger for arrhythmias is a well-documented cause of repolarization alternans Human studies have shown that active ischemia can be associated with visible as well as microvolt-level T-wave alternans While MTWA testing is traditionally used to evaluate arrhythmic risk this known association with ischemia may allow MTWA testing to be used as a diagnostic tool to detect underlying CAD The MTWA-CAD study will assess the feasibility of this concept by measuring MTWA during routine nuclear stress testing or stress echocardiography with treadmill exercise This is a feasibility study designed to verify preliminary observations under controlled environments and to generate hypotheses endpoints and sample sizes for future investigations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None