Coronary Artery DiseaseSLYM IINCT05250310
The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease
A study testing Chair Yoga in people with Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Chair Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 24 Oct 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for the study are 18-80 year old adults.
- Underwent percutaneous coronary intervention (PCI) at the catheterization lab of Mount Sinai Hospital (New York, New York) or have non-obstructive coronary artery disease and at least one CVD risk factor (hypertension, hypercholesterolemia, diabetes mellitus, or obesity) or metabolic abnormality (fasting plasma glucose ≥ 100 mg/dl, documented previous diagnosis of hypertension, serum triglycerides ≥ 150 mg/dl, or HDL cholesterol < 40 mg/dl).
- Subjects diagnosed with metabolic syndrome, which is defined as three or more of the following conditions: (1) Central or abdominal obesity (waist circumference > 40 inches for men and > 35 inches for women); (2) High triglycerides (≥150 mg/dL or triglycerides treatment); (3) Low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women) or low HDL-C treatment; (4) High blood pressure (≥130/85 mmHg) or antihypertensive medications; (5) High fasting glucose (≥100 mg/dL) or type 2 diabetes mellitus.
- Participants must be able to willingly consent to study participation and must be able to comply with the study requirements.
Who cannot join
- Physical/psychological limitation or unwillingness to practice yoga,
- Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants,
- Rheumatological/immunological diseases,
- History of transplant,
- Moderate to severe chronic obstructive pulmonary disease, debilitating or severe systemic Illness,
- Subjects who are pregnant or postpartum less than 6 months,
- Liver disease or alcohol use of more than 7 alcoholic drinks/week in women and more than 14 drinks/week in men
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD.
Read the detailed description
Cardiovascular disease (CVD) and metabolic syndrome (MetS) are major public health problems in the USA and worldwide. Yoga has been proven effective in numerous studies to improve cardiovascular risk factors, with a reduction in the risk of heart attacks and strokes. MicroRNAs (miRNAs) have recently emerged as key regulators of metabolism by playing a crucial role in cholesterol and lipid metabolism, fatty acid metabolism, insulin and glucose homeostasis. Yoga has been shown to induce a dynamic shift in miRNAs and reset their target genes expression associated with metabolites and pathways connected to CVD and MetS to a normal physiological state. 120 subjects will be included in the study. After recruitment, subjects will be randomized to one of two groups: Yoga (n=60) or Control (n=60) group. Patients randomized to Yoga, will practice yoga poses in a chair for 30 min at least 3 days a week by watching video instruction for 16 weeks. Control group patients will follow standard of care (SOC) treatment. At the enrollment day and at the 16-weeks follow-up visit, 15ml of blood will be collected from all participants for miRNAs expression profile.
- Conditions
- Coronary Artery Disease
- Being tested
- Chair Yoga
- Keywords
- Coronary artery disease, metabolic abnormality, chair yoga, micro RNA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chair YogaBehavioural
Yoga poses performed in a chair
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Active comparator | Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks Receives: Behavioral: Chair Yoga |
| Standard of Care | No intervention | Control group patients will follow standard of care (SOC) treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
micro RNA expression
Measured: End of study, at 22 months
Secondary outcomes (3)
Body weight
Body weight, kg
Measured: End of study, at 22 months
Waist circumference
Waist circumference, inches
Measured: End of study, at 22 months
Blood pressure
blood pressure
Measured: End of study, at 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start24 Jan 2022
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Why it stopped: We have closed the study as subjects were not interested in participating.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomization 1:1
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annapoorna Kini, Icahn School of Medicine at Mount Sinai
- Investigators
- Annapoorna Kini, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250310
- Sponsor's protocol ID
- GCO 15-2147
- Acronym
- SLYM II
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05250310
- Acronym / sponsor ID
- SLYM II / GCO 15-2147
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, metabolic abnormality, chair yoga, micro RNA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have closed the study as subjects were not interested in participating.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 22 Feb 2022 (actual)
- 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.
The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD.
Detailed description
Cardiovascular disease (CVD) and metabolic syndrome (MetS) are major public health problems in the USA and worldwide. Yoga has been proven effective in numerous studies to improve cardiovascular risk factors, with a reduction in the risk of heart attacks and strokes. MicroRNAs (miRNAs) have recently emerged as key regulators of metabolism by playing a crucial role in cholesterol and lipid metabolism, fatty acid metabolism, insulin and glucose homeostasis. Yoga has been shown to induce a dynamic shift in miRNAs and reset their target genes expression associated with metabolites and pathways connected to CVD and MetS to a normal physiological state. 120 subjects will be included in the study. After recruitment, subjects will be randomized to one of two groups: Yoga (n=60) or Control (n=60) group. Patients randomized to Yoga, will practice yoga poses in a chair for 30 min at least 3 days a week by watching video instruction for 16 weeks. Control group patients will follow standard of care (SOC) treatment. At the enrollment day and at the 16-weeks follow-up visit, 15ml of blood will be collected from all participants for miRNAs expression profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group randomization 1:1
| Arm | Type | Receives |
|---|---|---|
| Yoga | Active comparator | Behavioral: Chair YogaPatients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks |
| Standard of Care | No intervention | –Control group patients will follow standard of care (SOC) treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects eligible for the study are 18-80 year old adults.
- Underwent percutaneous coronary intervention (PCI) at the catheterization lab of Mount Sinai Hospital (New York, New York) or have non-obstructive coronary artery disease and at least one CVD risk factor (hypertension, hypercholesterolemia, diabetes mellitus, or obesity) or metabolic abnormality (fasting plasma glucose ≥ 100 mg/dl, documented previous diagnosis of hypertension, serum triglycerides ≥ 150 mg/dl, or HDL cholesterol < 40 mg/dl).
- Subjects diagnosed with metabolic syndrome, which is defined as three or more of the following conditions: (1) Central or abdominal obesity (waist circumference > 40 inches for men and > 35 inches for women); (2) High triglycerides (≥150 mg/dL or triglycerides treatment); (3) Low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women) or low HDL-C treatment; (4) High blood pressure (≥130/85 mmHg) or antihypertensive medications; (5) High fasting glucose (≥100 mg/dL) or type 2 diabetes mellitus.
- Participants must be able to willingly consent to study participation and must be able to comply with the study requirements.
Key exclusion criteria (7 listed)
- Physical/psychological limitation or unwillingness to practice yoga,
- Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants,
- Rheumatological/immunological diseases,
- History of transplant,
- Moderate to severe chronic obstructive pulmonary disease, debilitating or severe systemic Illness,
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 |
|---|---|---|
| Chair YogaYoga poses performed in a chair | Behavioural | Yoga |
Primary outcome
micro RNA expression
Time frame: End of study, at 22 months
3 secondary outcomes
Body weight
Time frame: End of study, at 22 months
Waist circumference
Time frame: End of study, at 22 months
Blood pressure
Time frame: End of study, at 22 months
Results and safety
The study was stopped early (reason given: We have closed the study as subjects were not interested in participating.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Annapoorna Kini, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chair Yoga in people with Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai 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 4 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 11 Feb 2026. 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: We have closed the study as subjects were not interested in participating.). 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?
micro RNA expression (time frame: End of study, at 22 months). 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 11 Feb 2026.