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

NCT02382250 | Completed

• 1 other identifier: 14-01623
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dietary Habits; Coronary Artery Disease; Lifestyle

Outcome Measures

Primary Outcomes (1)

• Change in dietary patterns/perception of lifestyle

  At time of enrollment, 1 month, 6 months

Secondary Outcomes (1)

• Association between dietary patterns/perception of lifestyle and degree of CAD and socioeconomic status

  At time of enrollment, 1 month, 6 months

Study Arms (1)

Catheterization Group

These are patients recruited from Bellevue Hospital and NYU Hospital Cardiac Catheterization Laboratories

Behavioral: Survey

Interventions

Survey BEHAVIORAL

Survey will be given to all participants

Catheterization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for coronary angiography at New York University Langone Medical Center and Bellevue Hospital Center. Subjects will include both men and women. Every effort will be made to include equitable numbers of each gender. Subjects more than 18 years of age will be eligible to participate in the study. The research in question applies to the entire adult population and therefore all adults may participate. Subjects of any racial or ethnic background may participate in the study. There will be no enrollment restrictions based on race or ethnic origin. The study will not include vulnerable subjects as defined by current regulations.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Feeding Behavior; Coronary Artery Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Binita Shah, MD, MS

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)