Coronary Artery DiseaseCERROS - PilotNCT06252350
CERROS Pilot Study
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Angiowave Imaging at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 8 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected to have coronary artery disease (CAD) who are undergoing diagnostic coronary angiography with or without possible percutaneous coronary intervention (PCI).
Who may be able to join
- Referred for clinically indicated coronary angiography
- ≥18 years of age
- Not pregnant
- English speaking
- Not imprisoned
- Able to provide written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease, Coronary Stenosis, Angina Pectoris, Chest Pain
- Keywords
- CAD, Coronary, Angina, PCI, Angiography
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease, Coronary Stenosis, Angina Pectoris, Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Segment-level percent diameter stenosis (%DS)
Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)
Measured: Periprocedural
Secondary outcomes (4)
Stenosis severity
Agreement in reader-adjudication of segment-level identification of mild/intermediate/severe stenosis
Measured: Periprocedural
Diagnostic quality
Percent of coronary segments qualitatively determined to be of adequate diagnostic image quality
Measured: Periprocedural
Radiation dose - SOC
Radiation dose (air kerma and dose-area product) for SOC-angiograms
Measured: Periprocedural
Radiation dose - STEP
Radiation dose (air kerma and dose-area product) for STEP-angiograms
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start22 Feb 2024
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiowave Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan D Madder, MD, Principal investigator, Corewell HealthSean P Madden, PhD, Study director, Angiowave ImagingAram Salzman, Study chair, Angiowave Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252350
- Sponsor's protocol ID
- CLN-PLAN-101v1
- Acronym
- CERROS - Pilot
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ryan TJ. The coronary angiogram and its seminal contributions to cardiovascular medicine over five decades. Circulation. 2002 Aug 6;106(6):752-6. doi: 10.1161/01.cir.0000024109.12658.d4. No abstract available.
PubMed 12163439The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.
PubMed 18082557Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. doi: 10.1016/S0146-6453(01)00004-5.
PubMed 11459599Andreassi MG, Cioppa A, Botto N, Joksic G, Manfredi S, Federici C, Ostojic M, Rubino P, Picano E. Somatic DNA damage in interventional cardiologists: a case-control study. FASEB J. 2005 Jun;19(8):998-9. doi: 10.1096/fj.04-3287fje. Epub 2005 Mar 31.
PubMed 15802491Karatasakis A, Brilakis HS, Danek BA, Karacsonyi J, Martinez-Parachini JR, Nguyen-Trong PJ, Alame AJ, Roesle MK, Rangan BV, Rosenfield K, Mehran R, Mahmud E, Chambers CE, Banerjee S, Brilakis ES. Radiation-associated lens changes in the cardiac catheterization laboratory: Results from the IC-CATARACT (CATaracts Attributed to RAdiation in the CaTh lab) study. Catheter Cardiovasc Interv. 2018 Mar 1;91(4):647-654. doi: 10.1002/ccd.27173. Epub 2017 Jul 14.
PubMed 28707381
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Radiation Reduction for Optimized Safety - Pilot Study
- ClinicalTrials.gov ID
- NCT06252350
- Acronym / sponsor ID
- CERROS - Pilot / CLN-PLAN-101v1
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease, Coronary Stenosis, Angina Pectoris, Chest Pain
- Keywords
- CAD, Coronary, Angina, PCI, Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Angiowave ImagingIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected to have coronary artery disease (CAD) who are undergoing diagnostic coronary angiography with or without possible percutaneous coronary intervention (PCI).
Key inclusion criteria (6 listed)
- Referred for clinically indicated coronary angiography
- ≥18 years of age
- Not pregnant
- English speaking
- Not imprisoned
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Segment-level percent diameter stenosis (%DS)
Time frame: Periprocedural
Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)
4 secondary outcomes
Stenosis severity
Time frame: Periprocedural
Diagnostic quality
Time frame: Periprocedural
Radiation dose - SOC
Time frame: Periprocedural
Radiation dose - STEP
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 12163439Ryan TJ. The coronary angiogram and its seminal contributions to cardiovascular medicine over five decades. Circulation. 2002 Aug 6;106(6):752-6. doi: 10.1161/01.cir.0000024109.12658.d4. No abstract available.
- Background: PubMed 18082557The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.
- Background: PubMed 11459599Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. doi: 10.1016/S0146-6453(01)00004-5.
- Background: PubMed 15802491Andreassi MG, Cioppa A, Botto N, Joksic G, Manfredi S, Federici C, Ostojic M, Rubino P, Picano E. Somatic DNA damage in interventional cardiologists: a case-control study. FASEB J. 2005 Jun;19(8):998-9. doi: 10.1096/fj.04-3287fje. Epub 2005 Mar 31.
- Background: PubMed 28707381Karatasakis A, Brilakis HS, Danek BA, Karacsonyi J, Martinez-Parachini JR, Nguyen-Trong PJ, Alame AJ, Roesle MK, Rangan BV, Rosenfield K, Mehran R, Mahmud E, Chambers CE, Banerjee S, Brilakis ES. Radiation-associated lens changes in the cardiac catheterization laboratory: Results from the IC-CATARACT (CATaracts Attributed to RAdiation in the CaTh lab) study. Catheter Cardiovasc Interv. 2018 Mar 1;91(4):647-654. doi: 10.1002/ccd.27173. Epub 2017 Jul 14.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan D Madder, MD principal investigator
Corewell Health
Sean P Madden, PhD study director
Angiowave Imaging
Aram Salzman study chair
Angiowave Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Angiowave Imaging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segment-level percent diameter stenosis (%DS) (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06252350, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.