NCT01677481

Brief Summary

The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

3.5 years

First QC Date

August 23, 2012

Last Update Submit

March 11, 2016

Conditions

Exposure to Ionizing Radiation

Outcome Measures

Primary Outcomes (1)

  • Air Kerma

    The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.

    1 day

Other Outcomes (1)

  • Operator radiation exposure

    1 day

Study Arms (3)

Femoral

Coronary angiography procedures performed using transfemoral access

Left radial access

Coronary angiography procedures performed using left radial access site.

Right radial Access

Coronary angiography procedures performed using Right radial access site.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred for diagnostic coronary angiography

You may qualify if:

  • All patients undergoing diagnostic coronary angiography

You may not qualify if:

  • non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

V.S. General Hospital

Ahmedabad, Gujarat, 380006, India

Location

Related Publications (1)

  • Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.

    PMID: 26210808DERIVED

Study Officials

  • Tejas M Patel, MD, DM

    Chief

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 3, 2012

Study Start

February 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)