Phase Analysis and Obstructive CAD on Rubidium PET

Coronary Artery Disease Clinical Trial

Official title:

Regional and Global Left Ventricular Mechanical Dyssynchrony in the Diagnosis of Obstructive Coronary Artery Disease on Rest and Regadenoson Stress Rubidium Myocardial Perfusion PET

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01840696
• Other study ID #: IRB00062632
• Secondary ID: REGA12I11
• Status: Withdrawn
• Phase: Phase 2
• First received: April 16, 2013
• Last updated: May 29, 2014
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels.

Phase analysis is a computer method that is applied after the PET test is done. It is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. That is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart.

This study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion PET studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. This information will be used as a proxy for poor blood supply. The gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Male or female patients

• referred for myocardial perfusion imaging for suspected obstructive CAD

• 18 years of age or older.

Exclusion Criteria:

• Contraindications to regadenoson radionuclide imaging including severe reactive airway disease, unstable crescendo angina, high grade AV block, caffeine within 24 hours

• Documented prior myocardial infarction

• Severe claustrophobia

• Patients who may be pregnant.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Regadenoson
Vasodilator stress testing

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress/rest differences in global left ventricular mechanical contraction bandwidth.	The investigators will measure the percent change in global left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.; Two patients were enrolled but the data were not analyzed.	Up to 12 months	No
Secondary	Stress/rest differences in segmental left ventricular mechanical contraction bandwidth.	The investigators will measure the percent change in segmental (each of 3 major coronary arteries) left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.	Up to 12 months	No