Radiation Exposure During Coronary Procedures According to Vascular Access

NCT04403815 | Unknown

• 1 other identifier: 1136
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trial's objective is to evaluate: i. if there's any difference between the operator radiation exposure during diagnostic coronary angiography and/or percutaneous coronary intervention (PCI) performed through right-side artery accesses (wrist transradial access and distal transradial access) versus left distal radial artery access ii. the relationship between operator radiation exposure and other clinical and procedural characteristics, to assess independent predictors of operator radiation exposure. Design of the study: prospective multicenter observational cohort registry (OCR). The purpose of this OCR is to assess the radiation exposure of interventional cardiologist during a diagnostic coronary angiography and/or PCI according to vascular access used (see above). Coronary angiography and PCI will be performed according to usual practice

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• mean operator radiation dose

  mean operator radiation dose at the torax (expressed in µSy)

  1 year

Secondary Outcomes (4)

• patient radiation exposure

  from beginning to end of coronary procedure

• mean fluoroscopy time

  1 year

• mean DAP-normalized operator dose

  1 year

• mean operator effective dose

  1 year

Study Arms (2)

right radial access

diagnostic coronary angiography and/or PCI performed through right wrist and distal ("snuffbox") radial access

Procedure: vascular access for coronary procedures

left distal radial access

diagnostic coronary angiography and/or PCI performed through left distal ("snuffbox") radial access

Procedure: vascular access for coronary procedures

Interventions

vascular access for coronary procedures PROCEDURE

comparison of x-rays exposition of interventional cardiologist according to vascular access used

left distal radial access; right radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all-comers undergoing to diagnostic coronary angiography and/or PCI through transradial access

You may qualify if:

• patients admitted for coronary diagnostic angiography in the setting of valvular disease, stable angina, suspected coronary artery disease, acute coronary syndrome with or without ST segment elevation myocardial infarction who underwent diagnostic coronary angiography through right radial, right distal radial and left distal radial access.
• patients admitted for ad-Hoc PCI through any radial access
• patients age \> 18 years-old
• signed informed consent

You may not qualify if:

• hemodynamic instability

Sponsors & Collaborators

• Azienda ULSS 3 Serenissima: lead

Central Study Contacts

Andrea pacchioni, MD

CONTACT

00390415794241; andreapacchioni@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 27, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share