| CTRI Number |
CTRI/2011/06/001811 [Registered on: 17/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
15/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical study comparing two non-invasive approaches to measuring the response of an artery to a sudden change in blood flow. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A-102 |
Protocol Number |
| U1111-1119-3946 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi R Kasliwal |
| Designation |
Chairman, Preventive & Clinical Cardiology |
| Affiliation |
Medanta Heart Institute |
| Address |
Ravi R. Kasliwal, MD
Chairman, Preventive & Clinical Cardiology
Medanta Heart Institute
Medanta - The Medicity
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4141414 |
| Fax |
0124-4834111 |
| Email |
rr.kasliwal@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi R. Kasliwal |
| Designation |
|
| Affiliation |
Medanta Heart Institute |
| Address |
Medanta Heart Institute
Medanta - The Medicity
Gurgaon
HARYANA
122001
India |
| Phone |
0124 4141414 |
| Fax |
0124 4834111 |
| Email |
rr.kasliwal@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Ravi R. Kasliwal |
| Designation |
|
| Affiliation |
|
| Address |
Medanta Heart Institute
Medanta - The Medicity
Gurgaon
HARYANA
122001
India |
| Phone |
0124 4141414 |
| Fax |
0124 4834111 |
| Email |
rr.kasliwal@medanta.org |
|
|
Source of Monetary or Material Support
|
| Everist Genomics
401 West Morgan Rd
Ann Arbor, Michigan 48108
USA |
|
|
Primary Sponsor
|
| Name |
Everist Genomics Inc |
| Address |
401 West Morgan Rd.,
Ann Arbor, Michigan 48108, USA |
| Type of Sponsor |
Other [Biotechnology company-Global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravi R. Kasliwal |
Medanta Heart Institute |
Medanta - The Medicity,Sector 38-122001
Gurgaon
HARYANA |
0124 4141414
0124 4834111
rr.kasliwal@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta-Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardiovascular disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANGIOEF-3000 |
Device will be used twice within a 2-week period (Study Day 1, then Study Day 8) |
| Comparator Agent |
brachial artery ultrasound imaging |
brachial artery ultrasound imaging will be used twice within a 2-week period (Study Day 1, then Study Day 8) |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximal percent flow-mediated dilation (%FMDmax) of the brachial artery |
%FMDmax is determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operator variability |
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. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a non-invasive, open-label, randomized, comparative, cross-over, single-center investigational study comparing a novel diagnostic device, AngioEF-3000, to standard brachial artery ultrasound imaging for measuring flow-mediated dilation (FMD) of the brachial artery (BA). The primary outcome is maximal percent FMD (%FMDmax) of the BA; secondary outcome: intra-operator variability. Expected total enrollment: 45 subjects. |