Use of Large Field of View During Image Acquisition for Coronary Angiography

NCT ID: NCT01334931

Last Updated: 2012-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exposure to Ionizing Radiation Occupational Exposure to Radiation Radiation Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Large field of view

Patients will have coronary angiography performed with large field of view lens

Group Type EXPERIMENTAL

Large field of view arm

Intervention Type RADIATION

Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)

Medium field of view

Patients will have coronary angiography performed with medium field of view lens

Group Type ACTIVE_COMPARATOR

Medium field of view

Intervention Type RADIATION

Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Large field of view arm

Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)

Intervention Type RADIATION

Medium field of view

Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Indication of diagnostic coronary angiography for suspected coronary artery disease
* Sign written consent form

Exclusion Criteria

* Therapeutics procedures
* Urgency/emergency procedures
* Previous CABG
* Severe valvular disease
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cristiano de Oliveira Cardoso

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristiano O Cardoso, MD, MSc

Role: STUDY_CHAIR

Instituto de Cardiologia do Rio Grande do Sul

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UP 4454/10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.