Cardiovascular DiseaseCRCNCT02136758
Cardiovascular Risk Clinic
A study testing CRC lifestyle modification program in people with Cardiovascular Disease and Coronary Artery Disease, run by Windber Research Institute at 1 site in United States.
Trial summary
This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Disease, Coronary Artery Disease, Hypertension
- What is being tested?
- CRC lifestyle modification program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age <18 years of age
- Unstable coronary syndromes, refractory congestive heart failure, uncontrolled arrhythmia, or high-grade uncorrected cardiac conduction abnormalities
- Any contraindication to components to Program, such as physical disabilities precluding stretching and aerobic exercise or medical conditions that preclude consumption of foods essential to Program diet
- Inability or unwillingness to give consent
- Significant left main stenosis (>50%) or ejection fraction <35% with no revascularization
- History of substance abuse (including alcohol) without self-certification of abstinence for at least three months
- Non-ambulatory (bedridden) individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Windber Research Institute
Windber, Pennsylvania, 15963
About this study
This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease.
Read the detailed description
The main hypothesis to be tested in the Cardiovascular Risk Clinic was: Can individualized therapeutic lifestyle plans in conjunction with molecular analysis lead to informative assessments of disease risk that can reduce risk factors for diabetes and cardiovascular disease.
Our main objectives were:
- To investigate the effect of lifestyle modification on: (1) physiological measurements of coronary artery disease (CAD) including carotid intima-media thickness (CIMT), exercise stress tests, blood pressure, body mass index (BMI), and weight; (2) plasma markers associated with development of CAD such as lipids and triglycerides; and (3) molecular characteristics such as gene expression signatures and protein profiles.
- To determine if patients with heart disease or risk factors that would promote heart disease can achieve and adhere to the goals of a lifestyle change program in a non-residential, out-patient setting.
- Conditions
- Cardiovascular Disease, Coronary Artery Disease, Hypertension, Diabetes, Obesity
- Being tested
- CRC lifestyle modification program
- Keywords
- lifestyle modification, diet, exercise, cardiovascular disease, gene expression, obesity
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Hypertension, Diabetes Mellitus, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC lifestyle modification programBehavioural
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | The intervention group participated in individualized therapeutic lifestyle plans to reduce cardiovascular risk. Participants were introduced to factors contributing to cardiovascular disease and met individually with a registered dietitian, exercise physiologist, stress management instructor, and psychologist to learn effective strategies for integrating healthy changes into their current lifestyle. Receives: Behavioral: CRC lifestyle modification program |
| Usual care controls | No intervention | Control group received standard care from their primary physicians, but did not participate in any component of the lifestyle program or receive any information, advice, or counseling regarding healthy lifestyle behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Change in BMI
Measured: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Secondary outcomes (2)
Blood Pressure
Change in systolic and diastolic BP
Measured: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Blood Lipids
Change in HDL, LDL, total cholesterol, and triglycerides
Measured: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2009
- Primary completionJun 2013
- Study completionJul 2013
Why it stopped: Funding cut due to government sequestration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windber Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Darrell L Ellsworth, PhD, Principal investigator, Windber Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136758
- Sponsor's protocol ID
- 08-07
- Other IDs
- W81XWH-10-2-0080
- Acronym
- CRC
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Clinic
- ClinicalTrials.gov ID
- NCT02136758
- Acronym / sponsor ID
- CRC / 08-07
- Conditions
- Cardiovascular Disease, Coronary Artery Disease, Hypertension, Diabetes, Obesity
- Keywords
- lifestyle modification, diet, exercise, cardiovascular disease, gene expression, obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding cut due to government sequestration
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Windber Research InstituteUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center
- Study start
- Apr 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease.
Detailed description
The main hypothesis to be tested in the Cardiovascular Risk Clinic was: Can individualized therapeutic lifestyle plans in conjunction with molecular analysis lead to informative assessments of disease risk that can reduce risk factors for diabetes and cardiovascular disease.
Our main objectives were:
- To investigate the effect of lifestyle modification on: (1) physiological measurements of coronary artery disease (CAD) including carotid intima-media thickness (CIMT), exercise stress tests, blood pressure, body mass index (BMI), and weight; (2) plasma markers associated with development of CAD such as lipids and triglycerides; and (3) molecular characteristics such as gene expression signatures and protein profiles.
- To determine if patients with heart disease or risk factors that would promote heart disease can achieve and adhere to the goals of a lifestyle change program in a non-residential, out-patient setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Behavioral: CRC lifestyle modification programThe intervention group participated in individualized therapeutic lifestyle plans to reduce cardiovascular risk. Participants were introduced to factors contributing to cardiovascular disease and met individually with a registered dietitian, exercise physiologist, stress management instructor, and psychologist to learn effective strategies for integrating healthy changes into their current lifestyle. |
| Usual care controls | No intervention | –Control group received standard care from their primary physicians, but did not participate in any component of the lifestyle program or receive any information, advice, or counseling regarding healthy lifestyle behaviors. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Age <18 years of age
- Unstable coronary syndromes, refractory congestive heart failure, uncontrolled arrhythmia, or high-grade uncorrected cardiac conduction abnormalities
- Any contraindication to components to Program, such as physical disabilities precluding stretching and aerobic exercise or medical conditions that preclude consumption of foods essential to Program diet
- Inability or unwillingness to give consent
- Significant left main stenosis (>50%) or ejection fraction <35% with no revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRC lifestyle modification programIntervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk. | Behavioural | Lifestyle modification |
Primary outcome
Body Mass Index
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Change in BMI
2 secondary outcomes
Blood Pressure
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Blood Lipids
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Results and safety
The study was stopped early (reason given: Funding cut due to government sequestration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Windber Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrell L Ellsworth, PhD principal investigator
Windber Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRC lifestyle modification program in people with Cardiovascular Disease and Coronary Artery Disease, run by Windber Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding cut due to government sequestration). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.