NCT06252350

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

February 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

15 days

First QC Date

February 2, 2024

Last Update Submit

March 9, 2024

Conditions

Coronary Artery DiseaseMyocardial InfarctionCoronary DiseaseCoronary StenosisAngina PectorisChest Pain

Keywords

CADCoronaryAnginaPCIAngiography

Outcome Measures

Primary Outcomes (1)

  • Segment-level percent diameter stenosis (%DS)

    Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)

    Periprocedural

Secondary Outcomes (4)

  • Stenosis severity

    Periprocedural

  • Diagnostic quality

    Periprocedural

  • Radiation dose - SOC

    Periprocedural

  • Radiation dose - STEP

    Periprocedural

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corewell Health West

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (5)

  • 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.

    PMID: 12163439BACKGROUND

  • The 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.

    PMID: 18082557BACKGROUND

  • Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. doi: 10.1016/S0146-6453(01)00004-5.

    PMID: 11459599BACKGROUND

  • Andreassi 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.

    PMID: 15802491BACKGROUND

  • Karatasakis 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.

    PMID: 28707381BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionCoronary DiseaseCoronary StenosisAngina PectorisChest Pain

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ryan D Madder, MD

    Corewell Health

    PRINCIPAL INVESTIGATOR

  • Sean P Madden, PhD

    Angiowave Imaging

    STUDY DIRECTOR

  • Aram Salzman

    Angiowave Imaging

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 9, 2024

Study Start

February 22, 2024

Primary Completion

March 8, 2024

Study Completion

March 8, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within 12 months
More information

Locations

US(1)