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

Protocol: A-102 Assessment of Vascular Reactivity by Novel Diagnostic Device, ANGIOEF-3000, compared to that using Brachial Artery Ultrasound Imaging -- Initial Experience in an Indian Population

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/06/001811
Enrollment
45
Registered
2011-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ANGIOEF-3000: Device will be used twice within a 2-week period (Study Day 1, then Study Day 8) Control Intervention1: brachial artery ultrasound imaging: brachial artery ultrasound imag

Sponsors

Everist Genomics Inc
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactRavi R. Kasliwal

Medanta Heart Institute

rr.kasliwal@medanta.org0124 4141414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026