Completed

Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Angiographic run with new algorithm and low dose (50% dose)

+ Angiographic run with predecessor algorithm and dose (100%)

Radiation
Who is being recruted

Cardiovascular Diseases

+ Vascular Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorPhilips Clinical & Medical Affairs Global
Last updated: March 8, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Fluoroscopically guided procedures are associated with a risk of radiation injury to the skin, caused by high peak skin dose. The increasingly complex nature of many of the interventions performed requires the use of significant amounts of radiation for their completion. Of particular relevance to dose reduction concerns are obese patients, for whom additional radiation is often necessary to obtained sufficient diagnostic quality, as well as patients suffering from chronic total coronary occlusions (CTO), for whom long procedures with extended radiation time and contrast usage are common. In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.

Principal SponsorPhilips Clinical & Medical Affairs Global
Last updated: March 8, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesVascular Diseases

Criteria

1 inclusion criteria required to participate
Patients older than 18 years of age undergoing coronary angiography

5 exclusion criteria prevent from participating
Patients already involved in a clinical trial

Patients not willing or unable to give consent to participate

Patients under the age of 18

Patients with severe kidney disease (eGFR < 60)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Angiographic run with new algorithm and low dose (50% dose)

Group II

Experimental
Angiographic run with predecessor algorithm and dose (100% dose)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Radboud University Nijmegen Medical Center

Nijmegen, NetherlandsOpen Radboud University Nijmegen Medical Center in Google Maps
CompletedOne Study Center