A clinical study comparing two non-invasive approaches to measuring the response of an artery to a sudden change in blood flow.

Not Applicable

• Registration Number: CTRI/2011/06/001811
• Lead Sponsor: Everist Genomics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

ECOG/Zubrod score performance status 0-1 (ECOG 0: Fully active, able to carry on all pre-disease performance without restriction; ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work)

Exclusion Criteria

Refractory atrial fibrillation or multifocal atrial tachycardia;
Frequent ventricular or atrial premature contractions;
Myocardial infarction or unstable angina within previous 90 d;
Congestive heart failure;
Significant valvular heart disease;
15 mm Hg or greater difference in systolic blood pressure between R and L arms;
History of axillary-subclavian venous thrombosis;
Arteriovenous fistula for hemodialysis;
History of lymph node dissection;
Diabetes mellitus for which subject is receiving insulin;
Vasospastic disorders manifested by Raynaud's phenomenon;
Active viral or bacterial infection;
Prescribed any new medication or had medication dose modification within previous 4 wks;
Body mass index greater than 50 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal percent flow-mediated dilation (%FMDmax) of the brachial arteryTimepoint: %FMDmax is determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery

Secondary Outcome Measures

Name	Time	Method
Intra-operator variabilityTimepoint: Compare %FMDmax determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery on Study Day 1 with %FMDmax determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery on Study Day 8.