Relationship Between Diet, Lifestyle, and the Severity of Coronary Artery Disease

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