Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04462159 |
| Other study ID # |
20-0073 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2020 |
| Est. completion date |
May 27, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Northwell Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of our project is to better understand the characteristics of the young patients
with coronary artery disease presenting for cardiac catheterization at our institution and to
put forth a program to optimize their risk factors with a focus on gender differences. We
will assess traditional and non-traditional risk factors, as well as genetics and
environment. These characteristics will be compared by gender to determine unique factors
related to women that could subsequently be targeted. The program will begin with universal
education about the process of atherosclerosis, risk factors contributing to the disease and
specific risk factor goals for each patient for the 6 month program. The patients will then
be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a
nutritional program with teaching kitchen component, and exercise instruction lead by an
exercise physiologist. Psychological support will be provided to address stress that impairs
quality of life, depression or anxiety to fully optimize the lifestyle component. These
sessions will be done virtually in order to comply with social distancing until in person
sessions can resume.
The investigational endpoints of this program will include a variety of cardiovascular
disease (CVD) risk factors, biomarkers, lifestyle behaviors, quality of life and
guideline-based medical regimen. At the end of this phase, we aim to both better understand
differences in risk factors and the interventions with the biggest impact in terms of risk
factor optimization in men vs. women.
Description:
After enrollment, participants will meet with researchers where baseline character-istics
will be obtained including biometrics such as weight, height, blood pressure, abdominal
circumference, etc., as well as a questionnaire that will include validat-ed screening tools
for the screening for depression, anxiety, and stress, which are considered non-traditional
risk factors for heart disease. The questionnaire will also include other aspects of the
participant's lifestyle that could help better understand their risk for heart disease. This
questionnaire will be available to be filled out on paper, via email which will be linked
with REDCap, and in a tablet provided by our team with the data also being uploaded directly
to REDCap.
Blood will also be collected by venipuncture (approximately 12milliliters, 6-8mL for standard
of care labs, and 3-4mL for research labs) to assess inflammatory markers, lipids and glucose
levels. If based on this initial screening, participants are thought to be at high risk for
genetic disease, which likely predisposed them to develop heart disease, they will be offered
genetic testing as part of their routine clinical care outside of this research, and an
additional consent form will then be provided. We are planning to only recommend genetic
testing as per clinical care in those for whom it is recommended by clinical guidelines. When
a patient is deemed eligible from a clinical standpoint, they will be referred to our cardio
ge-nomics team and be consented as per their clinical protocols and samples, either saliva or
blood acquired by venipuncture (about 5ml), will be obtained. Source of sample will be
determined by cardio genomics team and this will also fall under their standard of care. If
the patient is being enrolled in the outpatient setting and has lab work within the past
month, assuming no changes have been made to lipid lowering therapies during that time, we
will only need to draw 3-4mL for research labs and possibly one additional tube for
Lipoprotein A, as it is not commonly in-cluded in basic lab work.
During their initial consultation while in the hospital, their individual risk would be
assessed and the patient will receive counseling on how to further improve said risk. These
goals will be reinforced and measures to ensure those goals are met will be implemented when
the patient comes to clinic within 2 weeks from their cardiac catheterization. During that
visit, they will also be educated on the process of heart disease. Frequency of follow up in
clinic will be determined on an individual basis based on individual risk factors, however,
all patients are expected to be seen for a minimum of 3 times during those 6 months.
Soon after seeing us for that initial visit in clinic, the group risk reduction program will
begin and will last for 6 months with 2 sessions per month (every other week), out of which
participants will be required to attend at least 6 for maximum benefit. The sessions will
include an exercise and nutrition program.
The nutrition program will be given by a Registered Dietitian Nutritionist and it will
consist of a 60min session that will include about 10-15min education, 30min for a cooking
demonstration where participants will be able to participate in the process of making heart
healthy foods, and 10-15min for questions and answers. Food al-lergies will be reviewed prior
to initiation of each session.
The exercise portion of the program will be led by a RRCA Level 1 Certified Coach from
Achilles International and the exercise will be low level exercise, at a level lower than
even cardiac rehabilitation, which is usually recommended for patients after cardiac
procedures. Regardless, the patient's cardiologist will indicate in writ-ing that it is safe
to proceed with these sessions, which will be a 60min session provided by an exercise
specialist.
Both nutrition and exercise sessions will occur between 5:30-6:30pm or 6pm-7pm at the
Friedman Institute for Diabetes, and if the weather allows, some of the exer-cise sessions
will be at Central Park. If needed, participants can also see a psy-chologist. Once the risk
reduction program has ended, within a month we will re-evaluate the participants, repeat the
initial questionnaire (excluding the demo-graphic data, past medical history and family
history sections) and repeat blood work, with the exception of referral for genetic testing.
The registered dietitian and exercise coach are not considered investigators on this study as
they will be performing their routine job function and will not be giving any new or
different information to the participants of this study than what they would give to any
other person joining them who are not part of this study. Addi-tionally, they will not be
collecting any data either.
Results will be analyzed by gender with the intention to assess if some characteris-tics are
unique to women compared to men, and the impact of the program on risk factors will also be
assessed. Participants will also be called by one of the re-searchers about 1 month after the
program has finished to assess if any changes in their lifestyle have persisted after the
program, and once a year to follow up on cardiovascular events for 5yrs.
Addendum:
The Young Heart Study was designed to help subjects identify, educate, and reduce their risk
of cardiovascular disease. The original structure of the study was to hold in-person sessions
geared towards mental health, nutrition, and exercise. The widespread impact of COVID-19
forced the research team to pivot from the previ-ous model and include innovative virtual
supplemental content.
The Young Heart Study has developed 3 instructional videos in the areas of mental health,
nutrition, and exercise. These videos will be used in addition to physically distanced
in-person events in accordance with CDC recommendations. The virtual content will not replace
the original in-person events and is to be used in addition to the original study procedures.
The revised protocol is for ALL subjects to watch the video content and answer a short
experiential survey (included on separate document). This survey will help the research team
gauge impact of the videos and determine use case for the remain-der of the study.
The post-study survey provided after the 6 month period will be used to gauge perceived
improvement by participant, improve relevant data collection, and add additional qualitative
information to study team.
