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Radiation Shielding

Rampart IC, M1128 for Nuclear Radiation Emergency (RAMPART Trial)

N/A
Waitlist Available
Led By Varinder P Singh, M.D.
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

RAMPART Trial Summary

This trial is testing whether the Rampart IC, M1128 radiation protection system is better than lead aprons and ancillary shields at reducing orthopedic injuries and musculoskeletal pain from exposure to radiation.

RAMPART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in radiation attenuation

RAMPART Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Rampart M1128 IC, OnlyExperimental Treatment1 Intervention
Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers.
Group II: Lead Apron + Rampart IC, M1128Experimental Treatment1 Intervention
Consented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers.
Group III: Lead Apron OnlyActive Control1 Intervention
This is the control group. Consented providers will perform catherization procedures utilizing only the lead apron and ancillary shields (lead skirt, vest, thyroid collar (all at least 0.5mm Pb) with use of under table lead per lab operating policy and mobile suspended lead-acrylic shield and lead glasses). Radiation will be measured by dosimeters worn by the providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rampart IC, M1128 and Lead Apron
2022
N/A
~70
Rampart IC, M1128
2022
N/A
~70

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,870 Total Patients Enrolled
Varinder P Singh, M.D.Principal InvestigatorSenior Vice President, Cardiology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for participants in this research endeavor?

"The entry of this trial on clinicaltrials.gov confirms that recruitment has ceased; it was first published on March 9th 2022 and last modified July 21st 2022. Nevertheless, there are 8 other trials which require candidates at present."

Answered by AI
Recent research and studies
The American Journal of CardiologyJournal
Prevalence of Spinal Disc Disease Among Interventional Cardiologists
Ross, Allan M., Jerome Segal, David Borenstein, Ellen Jenkins, and Shuyan Cho. 1997. “Prevalence of Spinal Disc Disease Among Interventional Cardiologists”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/s0002-9149(96)00678-9.
Catheterization and Cardiovascular InterventionsJournal
Occupational Hazards of Interventional Cardiologists: Prevalence of Orthopedic Health Problems in Contemporary Practice
Goldstein, James A., Stephen Balter, Michael Cowley, John Hodgson, Lloyd W. Klein, and on behalf of the Interventional Committee of the Society of Cardiovascular Interventions. 2004. “Occupational Hazards of Interventional Cardiologists: Prevalence of Orthopedic Health Problems in Contemporary Practice”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.20201.
Occupational MedicineJournal
Biological Effects of Low-dose Ionizing Radiation Exposure on Interventional Cardiologists
Zakeri, F., T. Hirobe, and K. Akbari Noghabi. 2010. “Biological Effects of Low-dose Ionizing Radiation Exposure on Interventional Cardiologists”. Occupational Medicine. Oxford University Press (OUP). doi:10.1093/occmed/kqq062.
CirculationJournal
ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided Invasive Cardiovascular Procedures
WRITING COMMITTEE MEMBERS, John W. Hirshfeld Jr, Stephen Balter, Jeffrey A. Brinker, Morton J. Kern, Lloyd W. Klein, Bruce D. Lindsay, et al.. 2005. “ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided Invasive Cardiovascular Procedures”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.0000157946.29224.5d.
~20 spots leftby Apr 2025
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