CERROS Pilot Study (CERROS - Pilot)

March 9, 2024 updated by: Angiowave Imaging

Clinical Evaluation of Radiation Reduction for Optimized Safety - Pilot Study

The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.

Study Overview

Status

Completed

Conditions

Detailed Description

Coronary angiography is an essential diagnostic tool for determining the presence and severity of coronary artery disease, a leading cause of morbidity and mortality worldwide. While the basic techniques of coronary angiography have remained unchanged, the field of medical imaging has undergone significant advancements in hardware and software, offering new possibilities for enhanced visualization of the coronary arteries, better diagnostic accuracy, and improved patient and staff safety. However, the use of radiation during coronary angiography, which is necessary for image acquisition, exposes patients, physicians, and staff to potential risks, including radiation-induced tissue damage and an increased long-term risk of cancer. While the risks to patients attributable to the relatively low radiation doses they receive during single catheterization procedures are minimal, the cumulative risks of occupational radiation exposure are higher among physicians and staff, who are repetitively exposed to scattered radiation on a daily basis and accumulated over the course of years working in the catheterization laboratory. This occupational radiation exposure has been associated with an increased risk of cataracts, premature atherosclerosis, and certain cancers among physicians and staff. There is therefore a pressing need to explore strategies to minimize radiation doses used during coronary angiography without compromising the diagnostic accuracy of coronary artery disease detection.

Recent advancements in computational power and image processing algorithms provide opportunities for substantial reductions in radiation doses used during coronary angiography. One such advancement is spatiotemporal enhancement processing (STEP) which improves the signal to noise ratio of time sequenced angiographic data and enhances the visibility of vascular structure. This innovative STEP technique has the promise of minimizing patient and operator radiation exposure while maintaining adequate image quality. The purpose of this pilot study is to investigate a novel strategy of radiation dose reduction and data processing in coronary angiography. This pilot study will be performed in patients undergoing clinically-indicated diagnostic coronary angiography.

The study will compare angiograms acquired at ultralow radiation doses and processed with spatiotemporal enhancement software (STEP-angiograms) to standard of care angiograms (SOC-angiograms) acquired with normal radiation dose settings and no additional processing. The objectives are to assess offline whether the low radiation STEP-angiograms are of equivalent diagnostic quality as SOC-angiograms. In future research studies, the STEP software will be tested in the clinical setting to evaluate how the software may improve patient safety, enhance the overall quality of care, promote the responsible use of radiation in coronary angiography procedures, and reduce occupational radiation doses among physician and staff in the catheterization laboratory.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suspected to have coronary artery disease (CAD) who are undergoing diagnostic coronary angiography with or without possible percutaneous coronary intervention (PCI).

Description

Inclusion Criteria:

  • Referred for clinically indicated coronary angiography
  • ≥18 years of age
  • Not pregnant
  • English speaking
  • Not imprisoned
  • Able to provide written informed consent

Exclusion Criteria:

  • Hemodynamically or electrically unstable.
  • Indication for coronary angiography is emergent, including ST-segment elevation myocardial infarction
  • History of coronary artery bypass grafting
  • An eGFR <60
  • Pregnant or lactating
  • A BMI of 45 or greater
  • Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segment-level percent diameter stenosis (%DS)
Time Frame: Periprocedural
Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stenosis severity
Time Frame: Periprocedural
Agreement in reader-adjudication of segment-level identification of mild/intermediate/severe stenosis
Periprocedural
Diagnostic quality
Time Frame: Periprocedural
Percent of coronary segments qualitatively determined to be of adequate diagnostic image quality
Periprocedural
Radiation dose - SOC
Time Frame: Periprocedural
Radiation dose (air kerma and dose-area product) for SOC-angiograms
Periprocedural
Radiation dose - STEP
Time Frame: Periprocedural
Radiation dose (air kerma and dose-area product) for STEP-angiograms
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiowave Imaging

Investigators

  • Principal Investigator: Ryan D Madder, MD, Corewell Health
  • Study Director: Sean P Madden, PhD, Angiowave Imaging
  • Study Chair: Aram Salzman, Angiowave Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Actual)

March 8, 2024

Study Completion (Actual)

March 8, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-PLAN-101v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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