Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602583
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
To Determine the Difference in the Radiation Exposure With Low Dose Protocols for Angiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radiation Exposure in Diagnostic Angiography With and Without a New Low Dose Exposure Protocol -Radiation Exposure Reduction Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADRED
Brief Summary:
1 The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test stress myocardial stress imaging if indicated after a written and informed consent
2 Anthropometric and lab paraments would be recorded
3 Study will have 2 arms I A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose old low dose angiography
II A study arm 2 - a comparative arm where the patients being once eligible for the study would undergo angiography using the new low dose protocol
4 Post completion of the sample size the data of each angiographic view would be noted in both the study arms
2 Anthropometric and lab paraments would be recorded
3 Study will have 2 arms I A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose old low dose angiography
II A study arm 2 - a comparative arm where the patients being once eligible for the study would undergo angiography using the new low dose protocol
4 Post completion of the sample size the data of each angiographic view would be noted in both the study arms
Detailed Description:
INTRODUCTION
The increasing prevalence of cardiovascular diseases has led to a surge in the use of diagnostic angiography procedures While these procedures are crucial for diagnosing and treating heart conditions they also involve significant exposure to ionizing radiation Excessive radiation exposure can pose serious health risks including an increased risk of cancer and other adverse effects
The RADRED study aims to address the critical issue of radiation exposure in cardiology catheterization labs By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure
Several factors contribute to the need for such research Firstly the growing number of patients undergoing diagnostic angiography particularly elderly individuals and those with multiple comorbidities increases the cumulative radiation exposure to the population Secondly advancements in imaging technology have led to more complex procedures often requiring longer fluoroscopy times which can result in higher radiation doses Finally there is a growing awareness of the potential long-term health consequences of radiation exposure particularly for vulnerable populations
The RADRED study has the potential to make a significant contribution to the field of cardiology by demonstrating the feasibility and benefits of implementing a low dose exposure protocol in catheterization labs By reducing radiation exposure this protocol can help to protect the health of patients and healthcare providers while also improving the overall efficiency and cost-effectiveness of diagnostic angiography procedures AIM To study determine the difference in the radiation exposure in diagnostic angiography with and without a new low dose exposure protocol
OBJECTIVES Primary objective To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol
Secondary objectives
1 To evaluate the diagnostic image quality obtained with the new low dose exposure protocol compared to the standard protocol
2 To assess any potential limitations associated with the new low dose exposure protocol
STUDY DESIGN
Observational analytical cohort study
PARTICIPANTS
Inclusion criteria
Adult patients who qualify for a need of diagnostic angiography and are finally found to have normal epicardial coronaries eg
Pre aortic or mitral valve replacement angiography
TMT positive for inducible ischemia
SPECT MPI positive patients
Cradiologically symptomatic patients with ECG abnormalities who cannot be subjected to stress test
High risk pre transplant patients
Exclusion criteria
Those who are unwilling for study
Patients who come with STEMI or NSTEMI
STUDY METHOD
1 The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test stress myocardial stress imaging if indicated after a written and informed consent
2 Anthropometric and lab paraments would be recorded
3 Study will have 2 arms I A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose old low dose angiography
II A study arm 2 - a comparative arm where the patients being once eligible for the study would undergo angiography using the new low dose protocol
4 Post completion of the sample size the data of each angiographic view would be noted in both the study arms
PERIOD OF STUDY till completion of sample in study arm 2 each successive patient would be enrolled - cluster sample
PATIENT CONSENT
Appropriate approval will be obtained from IEC of the institute
STATISTCAL ANALYSIS Data will be compiled in an excel sheet for all the variables of interest and presented in the form of tables and graphs as appropriate
Measures of central tendency mean or median would be calculated for all quantitative variables along with measures of dispersion standard deviation or interquartile range Qualitative or categorical variables will be described as frequencies and proportions The investigators will use a t-test for independent samples to compare the means of radiation exposure All the statistical analysis will be carried out using Statistical Package for Social Sciences SPSS Inc Chicago IL version 220 for Windows at 5 level of significance ie p005 will be considered significant
ETHICAL JUSTIFICATION This study aims to evaluate the efficacy of a new low-dose radiation protocol for diagnostic angiography in cardiology Cath labs By comparing patient radiation exposure with and without the protocol the study seeks to reduce the cumulative radiation burden on patients especially those at higher risk due to age or underlying health conditions The increasing frequency of diagnostic angiography coupled with advancements in imaging technology leading to more complex procedures has resulted in a growing concern about the potential long-term health risks associated with radiation exposure This study addresses this critical issue by exploring the effectiveness of a new protocol designed to minimize radiation dose during these procedures
As such low dose protocol has never been used earlier there is a need for evaluating the same as to set new standards and protocols
The patients involved in the research project will be informed of the methods anticipated benefits and potential risks of the study and the discomfort it may cause and the remedies thereof
Written informed consent will be obtained Every precaution will be taken to respect the privacy and confidentiality of the patient
The parent has right to abstain from the study or to withdraw consent to participate at any time of the study without reprisal
Due care and caution will be taken at all stages to ensure that the patient is put to minimum risk or suffer from irreversible side effects and probably benefit from study
DISCLOSURES CONFLICT OF INTEREST NIL
The increasing prevalence of cardiovascular diseases has led to a surge in the use of diagnostic angiography procedures While these procedures are crucial for diagnosing and treating heart conditions they also involve significant exposure to ionizing radiation Excessive radiation exposure can pose serious health risks including an increased risk of cancer and other adverse effects
The RADRED study aims to address the critical issue of radiation exposure in cardiology catheterization labs By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure
Several factors contribute to the need for such research Firstly the growing number of patients undergoing diagnostic angiography particularly elderly individuals and those with multiple comorbidities increases the cumulative radiation exposure to the population Secondly advancements in imaging technology have led to more complex procedures often requiring longer fluoroscopy times which can result in higher radiation doses Finally there is a growing awareness of the potential long-term health consequences of radiation exposure particularly for vulnerable populations
The RADRED study has the potential to make a significant contribution to the field of cardiology by demonstrating the feasibility and benefits of implementing a low dose exposure protocol in catheterization labs By reducing radiation exposure this protocol can help to protect the health of patients and healthcare providers while also improving the overall efficiency and cost-effectiveness of diagnostic angiography procedures AIM To study determine the difference in the radiation exposure in diagnostic angiography with and without a new low dose exposure protocol
OBJECTIVES Primary objective To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol
Secondary objectives
1 To evaluate the diagnostic image quality obtained with the new low dose exposure protocol compared to the standard protocol
2 To assess any potential limitations associated with the new low dose exposure protocol
STUDY DESIGN
Observational analytical cohort study
PARTICIPANTS
Inclusion criteria
Adult patients who qualify for a need of diagnostic angiography and are finally found to have normal epicardial coronaries eg
Pre aortic or mitral valve replacement angiography
TMT positive for inducible ischemia
SPECT MPI positive patients
Cradiologically symptomatic patients with ECG abnormalities who cannot be subjected to stress test
High risk pre transplant patients
Exclusion criteria
Those who are unwilling for study
Patients who come with STEMI or NSTEMI
STUDY METHOD
1 The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test stress myocardial stress imaging if indicated after a written and informed consent
2 Anthropometric and lab paraments would be recorded
3 Study will have 2 arms I A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose old low dose angiography
II A study arm 2 - a comparative arm where the patients being once eligible for the study would undergo angiography using the new low dose protocol
4 Post completion of the sample size the data of each angiographic view would be noted in both the study arms
PERIOD OF STUDY till completion of sample in study arm 2 each successive patient would be enrolled - cluster sample
PATIENT CONSENT
Appropriate approval will be obtained from IEC of the institute
STATISTCAL ANALYSIS Data will be compiled in an excel sheet for all the variables of interest and presented in the form of tables and graphs as appropriate
Measures of central tendency mean or median would be calculated for all quantitative variables along with measures of dispersion standard deviation or interquartile range Qualitative or categorical variables will be described as frequencies and proportions The investigators will use a t-test for independent samples to compare the means of radiation exposure All the statistical analysis will be carried out using Statistical Package for Social Sciences SPSS Inc Chicago IL version 220 for Windows at 5 level of significance ie p005 will be considered significant
ETHICAL JUSTIFICATION This study aims to evaluate the efficacy of a new low-dose radiation protocol for diagnostic angiography in cardiology Cath labs By comparing patient radiation exposure with and without the protocol the study seeks to reduce the cumulative radiation burden on patients especially those at higher risk due to age or underlying health conditions The increasing frequency of diagnostic angiography coupled with advancements in imaging technology leading to more complex procedures has resulted in a growing concern about the potential long-term health risks associated with radiation exposure This study addresses this critical issue by exploring the effectiveness of a new protocol designed to minimize radiation dose during these procedures
As such low dose protocol has never been used earlier there is a need for evaluating the same as to set new standards and protocols
The patients involved in the research project will be informed of the methods anticipated benefits and potential risks of the study and the discomfort it may cause and the remedies thereof
Written informed consent will be obtained Every precaution will be taken to respect the privacy and confidentiality of the patient
The parent has right to abstain from the study or to withdraw consent to participate at any time of the study without reprisal
Due care and caution will be taken at all stages to ensure that the patient is put to minimum risk or suffer from irreversible side effects and probably benefit from study
DISCLOSURES CONFLICT OF INTEREST NIL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None