Coronary Artery Disease (CAD)NCT00308633
Endothelial Progenitor Cells and Nitric Oxide in Cardiac Rehabilitation Program Participants
An observational study of Coronary Artery Disease (CAD), run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
This study will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD)
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2006to 28 Dec 2007
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults older than 21 years.
- Coronary artery disease established by angiography.
- At least two months interval since myocardial infarction or coronary artery bypass surgery.
- At least one month interval since percutaneous coronary intervention or congestive heart failure symptoms.
- No medical condition that might prohibit safe participation in cardiac rehabilitation.
- Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
Who cannot join
- Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.
- Angina pectoris that is prolonged in duration (greater than 20 minutes), or does not respond to nitroglycerin (2 tablets) within 2 weeks of referral to the program.
- Subjects physically unable to perform cardiac rehabilitation protocol due to neurologic or orthopedic conditions.
- Women of childbearing age unless recent pregnancy test is negative.
- Lactating women.
- Implantable cardioverter-defibrillator (ICD)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Mechanism and Vascular Effects of Endothelial Progenitor Cell Mobilization in Patients With Coronary Artery Disease Undergoing Cardiac Rehabilitation
This study will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. EPCs are a kind of stem cell produced by the bone marrow that can develop into cells found in arteries and in the heart and, therefore, can repair diseased vessels. The study will examine whether the EPCs are affected by exercise and will look at how they may contribute to repair of cells lining the diseased arteries as a result of participation in the rehabilitation program.
People with coronary artery disease may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. CAD patients also to a treadmill exercise test.
Read more
Volunteers' participation ends at the screening visit. The blood drawn at screening is used to identify EPC specific genes to compare with the EPC genes from patients with CAD.
CAD patients participate in Suburban Hospital's cardiac rehabilitation program. The exercise portion of the program includes 36 sessions of about 60 minutes each, spaced over approximately 3 months. Patients have a baseline blood test at screening and repeat blood tests at the end of each month of participation in the rehabilitation program. Some of the blood will be used for genetic tests to see how genes of the EPCs are changed by the patient's participation in the rehabilitation program.
Read the detailed description
Exercise training has long been recommended as a means of improving effort tolerance and reducing morbidity and mortality in patients with coronary artery disease (CAD). One mechanism of benefit may be through improved endothelial function with enhanced nitric oxide (NO) bioactivity. Such an effect may augment blood flow to exercising skeletal muscle and to the myocardium, and reduce vascular inflammation, platelet activation and adherence which could diminish the risk of thrombosis. In 46 patients with CAD, participating in the Suburban Hospital cardiac rehabilitation program (Protocol 03-H-0086), we detected increases in circulating endothelial progenitor cells (EPCs), which may have the capacity to repair diseased or dysfunctional endothelium. In the last 23 participants (following amendment of the protocol) a subset showed increase in whole blood nitrite - a marker of intravascular NO - at completion of program. However, not all patients showed EPC mobilization or increased intravascular NO despite compliant program participation and improved effort tolerance. One possibility is that EPCs from patients who fail to derive vascular benefit as evidenced by increased intravascular NO may have different EPC gene expression profiles at baseline or in response to repetitive exercise, resulting in diminished protection of EPCs against oxidant stress with initiation of apoptosis, compared with EPC gene expression in patients who show evidence of EPC mobilization and endothelial repair. The purpose of our study is to 1) Prospectively demonstrate a relationship between EPC mobilization and increased whole blood nitrite as a marker of improved vascular NO bioactivity due to EPC mobilization, and 2) Determine EPC gene expression profiles, with a focus on activation or suppression of genes whose products regulate intravascular redox potential, apoptosis and growth factor and cytokine secretion. We hypothesize that activation or suppression of critical genes in EPCs at baseline or during exercise may determine EPC mobilization, endothelial differentiation and vascular repair potential as evidenced by increased intravascular NO.
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Cardiac Rehabilitation, Apoptosis, Gene Expression, Nitric Oxide, Reactive Oxygen Species, Coronary Artery Disease, CAD
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study start23 Mar 2006
- Primary completion28 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 55 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308633
- Sponsor's protocol ID
- 060122
- Other IDs
- 06-H-0122
- Status last verified
- 30 Oct 2009
- First submitted
- 28 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Dimmeler S, Aicher A, Vasa M, Mildner-Rihm C, Adler K, Tiemann M, Rutten H, Fichtlscherer S, Martin H, Zeiher AM. HMG-CoA reductase inhibitors (statins) increase endothelial progenitor cells via the PI 3-kinase/Akt pathway. J Clin Invest. 2001 Aug;108(3):391-7. doi: 10.1172/JCI13152.
PubMed 11489932Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.
PubMed 10725398Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.
PubMed 9020076
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Vascular Effects of Endothelial Progenitor Cell Mobilization in Patients With Coronary Artery Disease Undergoing Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT00308633
- Acronym / sponsor ID
- 060122
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Cardiac Rehabilitation, Apoptosis, Gene Expression, Nitric Oxide, Reactive Oxygen Species, Coronary Artery Disease, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 23 Mar 2006
- Primary completion
- 28 Dec 2007 (actual)
- First posted
- 29 Mar 2006 (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 will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. EPCs are a kind of stem cell produced by the bone marrow that can develop into cells found in arteries and in the heart and, therefore, can repair diseased vessels. The study will examine whether the EPCs are affected by exercise and will look at how they may contribute to repair of cells lining the diseased arteries as a result of participation in the rehabilitation program.
People with coronary artery disease may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. CAD patients also to a treadmill exercise test.
Volunteers' participation ends at the screening visit. The blood drawn at screening is used to identify EPC specific genes to compare with the EPC genes from patients with CAD.
CAD patients participate in Suburban Hospital's cardiac rehabilitation program. The exercise portion of the program includes 36 sessions of about 60 minutes each, spaced over approximately 3 months. Patients have a baseline blood test at screening and repeat blood tests at the end of each month of participation in the rehabilitation program. Some of the blood will be used for genetic tests to see how genes of the EPCs are changed by the patient's participation in the rehabilitation program.
Detailed description
Exercise training has long been recommended as a means of improving effort tolerance and reducing morbidity and mortality in patients with coronary artery disease (CAD). One mechanism of benefit may be through improved endothelial function with enhanced nitric oxide (NO) bioactivity. Such an effect may augment blood flow to exercising skeletal muscle and to the myocardium, and reduce vascular inflammation, platelet activation and adherence which could diminish the risk of thrombosis. In 46 patients with CAD, participating in the Suburban Hospital cardiac rehabilitation program (Protocol 03-H-0086), we detected increases in circulating endothelial progenitor cells (EPCs), which may have the capacity to repair diseased or dysfunctional endothelium. In the last 23 participants (following amendment of the protocol) a subset showed increase in whole blood nitrite - a marker of intravascular NO - at completion of program. However, not all patients showed EPC mobilization or increased intravascular NO despite compliant program participation and improved effort tolerance. One possibility is that EPCs from patients who fail to derive vascular benefit as evidenced by increased intravascular NO may have different EPC gene expression profiles at baseline or in response to repetitive exercise, resulting in diminished protection of EPCs against oxidant stress with initiation of apoptosis, compared with EPC gene expression in patients who show evidence of EPC mobilization and endothelial repair. The purpose of our study is to 1) Prospectively demonstrate a relationship between EPC mobilization and increased whole blood nitrite as a marker of improved vascular NO bioactivity due to EPC mobilization, and 2) Determine EPC gene expression profiles, with a focus on activation or suppression of genes whose products regulate intravascular redox potential, apoptosis and growth factor and cytokine secretion. We hypothesize that activation or suppression of critical genes in EPCs at baseline or during exercise may determine EPC mobilization, endothelial differentiation and vascular repair potential as evidenced by increased intravascular NO.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults older than 21 years.
- Coronary artery disease established by angiography.
- At least two months interval since myocardial infarction or coronary artery bypass surgery.
- At least one month interval since percutaneous coronary intervention or congestive heart failure symptoms.
- No medical condition that might prohibit safe participation in cardiac rehabilitation.
Key exclusion criteria (6 listed)
- Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.
- Angina pectoris that is prolonged in duration (greater than 20 minutes), or does not respond to nitroglycerin (2 tablets) within 2 weeks of referral to the program.
- Subjects physically unable to perform cardiac rehabilitation protocol due to neurologic or orthopedic conditions.
- Women of childbearing age unless recent pregnancy test is negative.
- Lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11489932Dimmeler S, Aicher A, Vasa M, Mildner-Rihm C, Adler K, Tiemann M, Rutten H, Fichtlscherer S, Martin H, Zeiher AM. HMG-CoA reductase inhibitors (statins) increase endothelial progenitor cells via the PI 3-kinase/Akt pathway. J Clin Invest. 2001 Aug;108(3):391-7. doi: 10.1172/JCI13152.
- Background: PubMed 10725398Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.
- Background: PubMed 9020076Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD), run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308633, which also lists 3 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 2 Jul 2017.