Relationship Between Diet, Lifestyle, and the Severity of Coronary Artery Disease
Relationship Between Diet, Lifestyle, and the Severity of Coronary Artery Disease
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 patterns/perception of
 lifestyle between baseline and one- month and six-month follow-up. Secondary measures will
 include association between dietary patterns/perception of lifestyle and degree of CAD and
 socioeconomic status.
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 (presence/absence 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 patient's 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 patient's relationship
 with their physician, and that the study constitutes research, that the information obtained
 will not be specifically helpful to the individual patient's 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 gender/race/ethnicity, 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-I/ARB, 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.
Inclusion Criteria:

 -  All patients fluent in English or Spanish who are referred for coronary angiography
 and are fully able to fill out the baseline questionnaires.

 Exclusion Criteria:

 -  Patients will be excluded if they 1) present with ST-segment elevation MI, 2) have
 previously undergone coronary revascularization, 3) do not consent or are unable to
 give consent, or 4) are unable to complete the baseline questionnaires