Coronary Heart DiseaseNCT00820313

A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers

A study testing Dr. Dean Ornish Program for Reversing Heart Disease in people with Coronary Heart Disease and Biomarkers of Cardiovascular Disease, run by Preventive Medicine Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Coronary Heart Disease, Biomarkers of Cardiovascular Disease
What is being tested?: Dr. Dean Ornish Program for Reversing Heart Disease
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteUnited States
Study dates: Oct 2006to May 2009
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eligible patients included those who had a diagnosis of coronary heart disease (CHD) from their physician or health plan, a diagnosis of diabetes, or at least 3 additional cardiac risk factors.
A diagnosis of CHD included:
having diagnosed CHD based on non-invasive testing such as exercise testing, nuclear imaging, echocardiogram or other test that clearly demonstrates ischemia
cardiac catheterization demonstrating CHD
eligibility for bypass surgery/PTCA and seeking a clinical alternative
coronary bypass surgery

Show all 20Show fewer

PTCA/stent
myocardial infarction.
Type I or Type II diabetics were eligible for the program.
For a participant to be included as a high-risk factor participant, the participant must have either a family history of premature CHD (1st-degree relative (male<55; female <65) with MI or sudden cardiac death) or be a male aged > 45 or a female aged > 55.
In addition, there must be at least two additional cardiovascular risk factors, including:
current cigarette smoking (within the past 5 years)
hypertension: BP > 140/90 mm Hg or on antihypertensive medication,
low HDL-C: <35 mg/dl or on medications for lipid therapy
elevated apolipoprotein(a): >30 mg/dl or on medications for elevated lipids
high total cholesterol: > 240 or on medications for elevated lipids
high LDL-C: >160 or on medications for elevated lipids
high sensitivity C-Reactive Protein: > 3 mg/dl and < 10 mg/dl
obesity: BMI > 30
Insulin Resistant State (Metabolic Syndrome X

Who cannot join

ischemic left main CHD, with an obstruction greater than 50%
significant (>70%) proximal left anterior descending artery disease and proximal left circumflex artery disease and an ejection fraction less than 50%, *unstable angina
hypotensive response to exercise (> 20mm Hg drop in systolic BP)
history of exercise induced ventricular tachycardia or 3rd degree heart block without evidence of current stability
CABG surgery within 4 weeks, unless approved by medical director
MI within one month, unless approved by medical director\

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HF, with functional limitation and unresponsive to medications
current tobacco user not concurrently enrolled in a smoking cessation program with 2-month history of smoking cessation
uncontrolled malignant ventricular arrhythmia despite medications and/or implantable cardiac defibrillator (ICD), unless approved by medical director, resides beyond a one-hour commute to the Program site, unless approved by Team, *history of substance abuse disorder (inc. ETOH) without documentation of a minimum one year of abstinence
history of a significant psychiatric disorder without documentation of minimum one-year stability
impaired cognitive function, such as dementia or delirium
English language literacy unless Program site can accommodate
non-ambulatory
uncooperative spouse or life partner, defined as obstructive in attitude or behavior
the patient is deemed to be potentially disruptive to group setting by the screening team.

Trial locations and contacts

1 site in 1 country.

United States1 site

Preventive Medicine Research Institute
Sausalito, California, 94965

Other trials in United States

About this study

Official title: Coronary Events, Risk Factors, and Quality of Life in Men and Women Enrolled in Intensive Lifestyle Interventions - A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers

The primary aim of the proposed research is to examine the relationship of lifestyle changes to new dietary, biomedical, and cellular parameters among new enrollees entering the "Dr. Dean Ornish Program for Reversing Heart Disease program" at 5 selected sites. Specifically, the investigators will add assessments of emerging cardiac risk factors (e.g., high sensitivity C-reactive protein [hsCRP], fibrinogen, lipoprotein(a) [Lp(a)], small, dense LDL, apolipoprotein B [apoB], apolipoprotein A-I [apo A1], the apoB/apoA1 ratio, homocysteine [Hcy], B-type natriuretic peptide [BNP], oxidized LDL, fasting insulin and waist-to-hip ratio [WHR]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty acids), and measures of social support and cognitive functioning to the already existing assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP).

Hypothesis 1: Participation in the lifestyle program will not only be associated with favorable changes in standard coronary risk factors and quality of life, but also with improvements in emerging cardiac risk factors [hsCRP, Hcy, BNP, fibrinogen, Lp(a), small, dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity] and psychosocial well-being (i.e., social support, and cognitive functioning).

Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging pathogenic dietary factors will be associated with improvements in both standard and emerging cardiac risk factors (e.g. Hcy, oxidized LDL).

Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with differential improvement in standard coronary risk factors, emerging risk factors, cellular aging, and psychosocial variables.

Conditions: Coronary Heart Disease, Biomarkers of Cardiovascular Disease
Being tested: Dr. Dean Ornish Program for Reversing Heart Disease
Keywords: Coronary Heart Disease, Biomarkers of Cardiovascular Disease, Health Related Quality of Life, Diabetes, Diet
Medical subject headings: Coronary Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dr. Dean Ornish Program for Reversing Heart DiseaseBehavioural
Exercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week.
Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day.
Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based).
Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program.

Study groups in NCT00820313
Study group	Role	What they receive
Lifestyle Intervention	Other	Comprehensive lifestyle intervention for reversal of heart disease Receives: Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

Biomarkers of Cardiovascular Disease
Measured: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Secondary outcomes (1)

Dietary Intake
Measured: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006May 2009

First posted12 Jan 2009 (estimated)
Study startOct 2006
Primary completionMay 2009 (estimated)
Study completionMay 2009 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Coronary Heart 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00820313
Sponsor's protocol ID: CPMC-26.096SLH
Other IDs: W81XHW-06-1-0565
Status last verified: Jan 2009
First submitted: 8 Jan 2009
Last updated: 12 Jan 2009
Results posted: No
Data monitoring committee: No

Publications

Govil SR, Weidner G, Merritt-Worden T, Ornish D. Socioeconomic status and improvements in lifestyle, coronary risk factors, and quality of life: the Multisite Cardiac Lifestyle Intervention Program. Am J Public Health. 2009 Jul;99(7):1263-70. doi: 10.2105/AJPH.2007.132852. Epub 2008 Oct 15.
PubMed 18923113
Pischke CR, Scherwitz L, Weidner G, Ornish D. Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Health Psychol. 2008 Sep;27(5):584-92. doi: 10.1037/0278-6133.27.5.584.
PubMed 18823185
Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442.
PubMed 18825581
Frattaroli J, Weidner G, Merritt-Worden TA, Frenda S, Ornish D. Angina pectoris and atherosclerotic risk factors in the multisite cardiac lifestyle intervention program. Am J Cardiol. 2008 Apr 1;101(7):911-8. doi: 10.1016/j.amjcard.2007.11.039. Epub 2008 Jan 28.
PubMed 18359307
Pischke CR, Weidner G, Elliott-Eller M, Ornish D. Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of <or=40% or >40% in the Multicenter Lifestyle Demonstration Project. Eur J Heart Fail. 2007 Sep;9(9):928-34. doi: 10.1016/j.ejheart.2007.05.009. Epub 2007 Jun 14.
PubMed 17572148
Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007 Feb;33(1):57-68. doi: 10.1207/s15324796abm3301_7.
PubMed 17291171
Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
PubMed 16094059
Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
PubMed 9863851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coronary Events, Risk Factors, and Quality of Life in Men and Women Enrolled in Intensive Lifestyle Interventions - A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
ClinicalTrials.gov ID: NCT00820313
Acronym / sponsor ID: CPMC-26.096SLH
Conditions: Coronary Heart Disease, Biomarkers of Cardiovascular Disease
Keywords: Coronary Heart Disease, Biomarkers of Cardiovascular Disease, Health Related Quality of Life, Diabetes, Diet
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 131 participants (actual)
Lead sponsor: Preventive Medicine Research InstituteUniversity, hospital or other
Study start: Oct 2006
Primary completion: May 2009 (estimated)
Study completion: May 2009 (estimated)
First posted: 12 Jan 2009 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lifestyle Intervention	Other	Behavioral: Dr. Dean Ornish Program for Reversing Heart DiseaseComprehensive lifestyle intervention for reversal of heart disease

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Eligible patients included those who had a diagnosis of coronary heart disease (CHD) from their physician or health plan, a diagnosis of diabetes, or at least 3 additional cardiac risk factors.
A diagnosis of CHD included:
Type I or Type II diabetics were eligible for the program.
For a participant to be included as a high-risk factor participant, the participant must have either a family history of premature CHD (1st-degree relative (male<55; female <65) with MI or sudden cardiac death) or be a male aged > 45 or a female aged > 55.
In addition, there must be at least two additional cardiovascular risk factors, including:

Key exclusion criteria (15 listed)

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
Dr. Dean Ornish Program for Reversing Heart DiseaseExercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week. Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day. Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based). Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program.	Behavioural	Lifestyle Intervention

Primary outcome

Biomarkers of Cardiovascular Disease
Time frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

1 secondary outcome

Dietary Intake
Time frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
Background: PubMed 18923113Govil SR, Weidner G, Merritt-Worden T, Ornish D. Socioeconomic status and improvements in lifestyle, coronary risk factors, and quality of life: the Multisite Cardiac Lifestyle Intervention Program. Am J Public Health. 2009 Jul;99(7):1263-70. doi: 10.2105/AJPH.2007.132852. Epub 2008 Oct 15.
Background: PubMed 18823185Pischke CR, Scherwitz L, Weidner G, Ornish D. Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Health Psychol. 2008 Sep;27(5):584-92. doi: 10.1037/0278-6133.27.5.584.
Background: PubMed 18825581Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442.
Background: PubMed 18359307Frattaroli J, Weidner G, Merritt-Worden TA, Frenda S, Ornish D. Angina pectoris and atherosclerotic risk factors in the multisite cardiac lifestyle intervention program. Am J Cardiol. 2008 Apr 1;101(7):911-8. doi: 10.1016/j.amjcard.2007.11.039. Epub 2008 Jan 28.
Background: PubMed 17572148Pischke CR, Weidner G, Elliott-Eller M, Ornish D. Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of <or=40% or >40% in the Multicenter Lifestyle Demonstration Project. Eur J Heart Fail. 2007 Sep;9(9):928-34. doi: 10.1016/j.ejheart.2007.05.009. Epub 2007 Jun 14.
Background: PubMed 17291171Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007 Feb;33(1):57-68. doi: 10.1207/s15324796abm3301_7.
Background: PubMed 16094059Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
Background: PubMed 9863851Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
Preventive Medicine Research Institute website homepageLink provided by the sponsor.

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Active, not recruiting
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RecruitingObservational study
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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.

Edward Kersh, MD, FACC principal investigator

St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc

Dean Ornish, MD principal investigator

Preventive Medicine Research Institute

Gerdi Weidner, PhD principal investigator

Preventive Medicine Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Jan 2009. 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?

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?

Biomarkers of Cardiovascular Disease (time frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820313, which also lists 8 linked publications.

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 12 Jan 2009.