Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02382250
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2015-03-02
Brief Title:
Relationship Between Diet Lifestyle and the Severity of Coronary Artery Disease
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
The Relationship Between Diet Perception of Healthy Lifestyle and the Severity of Coronary Artery Disease in Patients Referred for Coronary Angiography
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective study of patients referred for coronary angiography at Bellevue Hospital Center and NYU Langone Medical Center Subjects enrolled in this study will complete two one-page questionnaires including information about diet lifestyle perceptions of health and perceived barriers to healthy lifestyles Patients will be contacted at one and six months following their procedure to complete follow-up questionnaires to assess changes in diet and perceptions of their health after knowing the results of their coronary angiogram The primary outcome measure will be change in dietary patternsperception of lifestyle between baseline and one- month and six-month follow-up Secondary measures will include association between dietary patternsperception of lifestyle and degree of CAD and socioeconomic status
Detailed Description:
Purpose of the study Dietary choices are influenced by individual barriers and perceptions of health and therefore information on both factors are needed to gain better insight into overall dietary health The aim of this study is to examine if patients knowledge of their coronary anatomy leads to dietary changes or changes in perception of health after a pre-specified follow-up time period in a ethnically racially and socioeconomically diverse patient population presenting for cardiac catheterization
Study Design The proposed study is a prospective study of patients referred for coronary angiography Subjects enrolled in this study will complete a questionnaire including information about diet lifestyle perceptions of health and perceived barriers to healthy lifestyles Demographics information regarding medical comorbidities including two questions on depression baseline laboratory data already collected for clinical purposes and angiographic data presenceabsence of CAD and severity will be collected Patients will be contacted by telephone at one and six months following their procedure to complete the two one-page questionnaires again On follow-up patients will also be asked if they have made changes to their diet using their completed dietary survey as a guide Both at baseline and on follow-up the questionnaires will be administered verbally to be consistent The purpose of this follow-up is to determine if a patients knowledge of their coronary disease status affects short- and long-term changes in diet and perception of health The primary outcome measure will be change in questionnaire response between baseline and follow-up
Methods and Procedures Subjects for study participation will include all patients age 18 and older referred to New York University Medical Center and Bellevue Hospital for diagnostic coronary angiography that are able to complete the baseline questionnaire
Consent and recruitment will be conducted in accordance of the policies of the New York University IRB and federal guidelines For the cardiac catheterization group the attending interventional cardiologists will be contacted to determine if a potential subject is willing to be approached for the study Informed consent will be sought and documented from all subjects upon referral The Principal Investigator or her appointed designee will explain the rationale procedures and potential risks of theprocedures in the study to each participant Each subject will be told that participation in the study described in this proposal is strictly voluntary that refusal to participate will not alter the patients relationship with their physician and that the study constitutes research that the information obtained will not be specifically helpful to the individual patients care After the subject has read the consent form comprehension of the key elements of the study procedures and risks will be tested with verbal questions of the consent form content If the subject is willing to participate the subject will sign the IRB-approved informed consent form Subjects will be given a copy of the consent form at the time it is obtained
Study Technique Patients meeting the inclusion and exclusion criteria in both groups will complete two one-page questionnaires uploaded in research navigator one about diet and one about perceptions of health and perceived barriers to healthy lifestyles Both of these questionnaires will be administered verbally at baseline and one- and six-month telephone follow-up Baseline demographic information and medical information will be obtained from the patient and chart in both groups outlined below Information regarding medications laboratory data and procedural data will be obtained from the medical chart outlined below At the conclusion of the coronary angiography procedure information regarding the severity of CAD will be recorded
Data Collection
The following baseline variables will be prospectively collected
Baseline Variables
Demographics including genderraceethnicity body mass index abdominal circumference education and income level race-ethnicity self-reported other variables measured
Medical history Previous MI previous coronary revascularization hypertension diabetes mellitus hyperlipidemia peripheral vascular disease previous stroke or transient ischemic attack carotid artery or peripheral artery disease moderate or severe or history of prior repair and tobacco and alcohol use collected from medical records and confirmed by patient
Medications Beta blocker diuretic ACE-IARB aspirin thienopyridine anticoagulants statin fibrates niacin fish oil ezetimibe bile acid sequestrant glucose-lowering medications collected from medical records and confirmed by patient
Laboratory data serum creatinine lipid panel hemoglobin A1c ejection fraction normal mild to moderately reduced or severely reduced left ventricular systolic function Collected from medical records Procedural data Collected from catheterization report and review of films
Indication for coronary angiography determined by research team according to data provided in medical records
Vessels affected
Degree of stenosis within the coronary arteries
Post-procedural recommendations Medical management PCI or coronary artery bypass surgery
If PCI performed collected from catheterization report
Vessel treated left main left anterior descending left circumflex right coronary artery saphenous vein graft arterial graft and single vessel or multivessel intervention
Type of lesion treated de novo or restenotic chronic total occlusion long lesion bifurcation lesion calcification thrombus lesion site ostial proximal mid-vessel distal and number of lesions treated
Procedural success defined as residual stenosis 20 at the end of procedure All electronic data will be de-identified and reside on password-protected computer All hard copy of data will be secured in a locked cabinet in a locked office on NYU Medical Center property
Data Analysis and Data Monitoring Results from diet and perception questionnaires will be compared between baseline and one-month and six-month follow-up using paired sample tests This comparison will be further analyzed by degree of CAD as defined by angiographic findings The risks associated with this study are deemed minimal There will be no intervention or change in the care of the subjects only data collection Therefore a Data Safety Monitoring Committee will not be required The investigators will review data on a quarterly basis or more often as necessary to ensure the safe and proper treatment of subjects
Subject Identification Recruitment and Consent Subjects will be screened and recruited when they are referred to the NYU or Bellevue cardiac catheterization laboratory for clinically indicated coronary angiography Informed consent will be obtained by the study investigator or designated appointee prior to coronary angiography
Study Design The proposed study is a prospective study of patients referred for coronary angiography Subjects enrolled in this study will complete a questionnaire including information about diet lifestyle perceptions of health and perceived barriers to healthy lifestyles Demographics information regarding medical comorbidities including two questions on depression baseline laboratory data already collected for clinical purposes and angiographic data presenceabsence of CAD and severity will be collected Patients will be contacted by telephone at one and six months following their procedure to complete the two one-page questionnaires again On follow-up patients will also be asked if they have made changes to their diet using their completed dietary survey as a guide Both at baseline and on follow-up the questionnaires will be administered verbally to be consistent The purpose of this follow-up is to determine if a patients knowledge of their coronary disease status affects short- and long-term changes in diet and perception of health The primary outcome measure will be change in questionnaire response between baseline and follow-up
Methods and Procedures Subjects for study participation will include all patients age 18 and older referred to New York University Medical Center and Bellevue Hospital for diagnostic coronary angiography that are able to complete the baseline questionnaire
Consent and recruitment will be conducted in accordance of the policies of the New York University IRB and federal guidelines For the cardiac catheterization group the attending interventional cardiologists will be contacted to determine if a potential subject is willing to be approached for the study Informed consent will be sought and documented from all subjects upon referral The Principal Investigator or her appointed designee will explain the rationale procedures and potential risks of theprocedures in the study to each participant Each subject will be told that participation in the study described in this proposal is strictly voluntary that refusal to participate will not alter the patients relationship with their physician and that the study constitutes research that the information obtained will not be specifically helpful to the individual patients care After the subject has read the consent form comprehension of the key elements of the study procedures and risks will be tested with verbal questions of the consent form content If the subject is willing to participate the subject will sign the IRB-approved informed consent form Subjects will be given a copy of the consent form at the time it is obtained
Study Technique Patients meeting the inclusion and exclusion criteria in both groups will complete two one-page questionnaires uploaded in research navigator one about diet and one about perceptions of health and perceived barriers to healthy lifestyles Both of these questionnaires will be administered verbally at baseline and one- and six-month telephone follow-up Baseline demographic information and medical information will be obtained from the patient and chart in both groups outlined below Information regarding medications laboratory data and procedural data will be obtained from the medical chart outlined below At the conclusion of the coronary angiography procedure information regarding the severity of CAD will be recorded
Data Collection
The following baseline variables will be prospectively collected
Baseline Variables
Demographics including genderraceethnicity body mass index abdominal circumference education and income level race-ethnicity self-reported other variables measured
Medical history Previous MI previous coronary revascularization hypertension diabetes mellitus hyperlipidemia peripheral vascular disease previous stroke or transient ischemic attack carotid artery or peripheral artery disease moderate or severe or history of prior repair and tobacco and alcohol use collected from medical records and confirmed by patient
Medications Beta blocker diuretic ACE-IARB aspirin thienopyridine anticoagulants statin fibrates niacin fish oil ezetimibe bile acid sequestrant glucose-lowering medications collected from medical records and confirmed by patient
Laboratory data serum creatinine lipid panel hemoglobin A1c ejection fraction normal mild to moderately reduced or severely reduced left ventricular systolic function Collected from medical records Procedural data Collected from catheterization report and review of films
Indication for coronary angiography determined by research team according to data provided in medical records
Vessels affected
Degree of stenosis within the coronary arteries
Post-procedural recommendations Medical management PCI or coronary artery bypass surgery
If PCI performed collected from catheterization report
Vessel treated left main left anterior descending left circumflex right coronary artery saphenous vein graft arterial graft and single vessel or multivessel intervention
Type of lesion treated de novo or restenotic chronic total occlusion long lesion bifurcation lesion calcification thrombus lesion site ostial proximal mid-vessel distal and number of lesions treated
Procedural success defined as residual stenosis 20 at the end of procedure All electronic data will be de-identified and reside on password-protected computer All hard copy of data will be secured in a locked cabinet in a locked office on NYU Medical Center property
Data Analysis and Data Monitoring Results from diet and perception questionnaires will be compared between baseline and one-month and six-month follow-up using paired sample tests This comparison will be further analyzed by degree of CAD as defined by angiographic findings The risks associated with this study are deemed minimal There will be no intervention or change in the care of the subjects only data collection Therefore a Data Safety Monitoring Committee will not be required The investigators will review data on a quarterly basis or more often as necessary to ensure the safe and proper treatment of subjects
Subject Identification Recruitment and Consent Subjects will be screened and recruited when they are referred to the NYU or Bellevue cardiac catheterization laboratory for clinically indicated coronary angiography Informed consent will be obtained by the study investigator or designated appointee prior to coronary angiography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None