Coronary Artery DiseaseNCT02674659

The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery

A study testing resistance training and aerobic training in people with Coronary Artery Disease, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of PCSK9 level on that group to another group who receives conventional rehabilitation program (only aerobic exercise) Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: resistance training and aerobic training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: No sites listed yet
Study dates: 10 Feb 2016to 18 Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

post elective coronary artery bypass surgery
> 18 years old
sign informed consent

Who cannot join

contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic > 160 mmHg diastolic > 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)
musculoskeletal pain, visual analog scale >3
post congenital heart disease surgery
post elective coronary artery bypass surgery with malfunction valves (operated or not)

About this study

Official title: The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery

Read the detailed description

The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.

Resistance training will be given by professional trainer in gymnasium of National Cardiovascular Center Harapan Kita supervised by cardiologists, following rules from American College of Sports Medicine guideline regarding to exercise after cardiac event.

Conditions: Coronary Artery Disease
Being tested: resistance training, aerobic training
Keywords: resistance training, PCSK9, coronary artery bypass grafting
Medical subject headings: Coronary Artery Disease, Hypercholesterolemia, Autosomal Dominant, 3

What participants receive

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

resistance trainingBehavioural
resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.
aerobic trainingBehavioural
aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)

Study groups in NCT02674659
Study group	Role	What they receive
Control group	Experimental	Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only) Receives: Behavioral: aerobic training
Intervention group	Experimental	Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well) Receives: Behavioral: resistance training; Behavioral: aerobic training

What is being measured

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

PCSK-9 Level
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

Secondary outcomes (8)

Low Density Lipoprotein
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Body Mass Index
Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
High-Density Lipoprotein
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Total Cholesterol
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Triglyceride
This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Fasting Blood Glucose
Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Systolic Blood Pressure
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Diastolic Blood Pressure
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Measured: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

Timeline

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

10 Feb 201618 Dec 2016

First posted4 Feb 2016 (estimated)
Study start10 Feb 2016
Primary completion23 Sep 2016
Study completion18 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Coronary Artery 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: Single blind
Who is masked: Participant
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02674659
Sponsor's protocol ID: RUHK-2016
Status last verified: Jan 2020
First submitted: 2 Feb 2016
Last updated: 21 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.
PubMed 15121495
Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.
PubMed 21896934
Ghroubi S, Elleuch W, Abid L, Abdenadher M, Kammoun S, Elleuch MH. Effects of a low-intensity dynamic-resistance training protocol using an isokinetic dynamometer on muscular strength and aerobic capacity after coronary artery bypass grafting. Ann Phys Rehabil Med. 2013 Mar;56(2):85-101. doi: 10.1016/j.rehab.2012.10.006. Epub 2012 Dec 7.
PubMed 23414745
Busch JC, Lillou D, Wittig G, Bartsch P, Willemsen D, Oldridge N, Bjarnason-Wehrens B. Resistance and balance training improves functional capacity in very old participants attending cardiac rehabilitation after coronary bypass surgery. J Am Geriatr Soc. 2012 Dec;60(12):2270-6. doi: 10.1111/jgs.12030. Epub 2012 Nov 23.
PubMed 23176104
Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Aug 26.
PubMed 26081791
Urban D, Poss J, Bohm M, Laufs U. Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis. J Am Coll Cardiol. 2013 Oct 15;62(16):1401-8. doi: 10.1016/j.jacc.2013.07.056. Epub 2013 Aug 21.
PubMed 23973703
Kim HS, Wu Y, Lin SJ, Deerochanawong C, Zambahari R, Zhao L, Zhang Q, Yan P. Current status of cholesterol goal attainment after statin therapy among patients with hypercholesterolemia in Asian countries and region: the Return on Expenditure Achieved for Lipid Therapy in Asia (REALITY-Asia) study. Curr Med Res Opin. 2008 Jul;24(7):1951-63. doi: 10.1185/03007990802138731. Epub 2008 Jun 10.
PubMed 18547466
Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
PubMed 23128163
Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. doi: 10.1056/NEJMoa054013.
PubMed 16554528
Lagace TA, Curtis DE, Garuti R, McNutt MC, Park SW, Prather HB, Anderson NN, Ho YK, Hammer RE, Horton JD. Secreted PCSK9 decreases the number of LDL receptors in hepatocytes and in livers of parabiotic mice. J Clin Invest. 2006 Nov;116(11):2995-3005. doi: 10.1172/JCI29383.
PubMed 17080197
Zhang DW, Lagace TA, Garuti R, Zhao Z, McDonald M, Horton JD, Cohen JC, Hobbs HH. Binding of proprotein convertase subtilisin/kexin type 9 to epidermal growth factor-like repeat A of low density lipoprotein receptor decreases receptor recycling and increases degradation. J Biol Chem. 2007 Jun 22;282(25):18602-18612. doi: 10.1074/jbc.M702027200. Epub 2007 Apr 23.
PubMed 17452316
Wen S, Jadhav KS, Williamson DL, Rideout TC. Treadmill Exercise Training Modulates Hepatic Cholesterol Metabolism and Circulating PCSK9 Concentration in High-Fat-Fed Mice. J Lipids. 2013;2013:908048. doi: 10.1155/2013/908048. Epub 2013 Jun 19.
PubMed 23862065
European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.
PubMed 20643803
Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, Faggiano P, Dei Cas L. The 6-min walking test early after cardiac surgery. Reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007 Nov;32(5):724-9. doi: 10.1016/j.ejcts.2007.08.013. Epub 2007 Sep 18.
PubMed 17881241
Wang J, Yu W, Zhao D, Liu N, Yu Y. In-Hospital and Long-Term Mortality in 35,173 Chinese Patients Undergoing Coronary Artery Bypass Grafting in Beijing: Impact of Sex, Age, Myocardial Infarction, and Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):26-31. doi: 10.1053/j.jvca.2016.08.004. Epub 2016 Aug 4.
PubMed 27771273

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery
ClinicalTrials.gov ID: NCT02674659
Acronym / sponsor ID: RUHK-2016
Conditions: Coronary Artery Disease
Keywords: resistance training, PCSK9, coronary artery bypass grafting
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
Study start: 10 Feb 2016 (actual)
Primary completion: 23 Sep 2016 (actual)
Study completion: 18 Dec 2016 (actual)
First posted: 4 Feb 2016 (estimated)
Results: Posted 9 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control group	Experimental	Behavioral: aerobic trainingPatients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)
Intervention group	Experimental	Behavioral: resistance training, Behavioral: aerobic trainingPatients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

post elective coronary artery bypass surgery
> 18 years old
sign informed consent

Key exclusion criteria (4 listed)

contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic > 160 mmHg diastolic > 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)
musculoskeletal pain, visual analog scale >3
post congenital heart disease surgery
post elective coronary artery bypass surgery with malfunction valves (operated or not)

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
resistance trainingresistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.	Behavioural	Intervention group
aerobic trainingaerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)	Behavioural	Control group, Intervention group

Primary outcome

PCSK-9 Level
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method

8 secondary outcomes

Low Density Lipoprotein
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Body Mass Index
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
High-Density Lipoprotein
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Total Cholesterol
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Triglyceride
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Fasting Blood Glucose
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Systolic Blood Pressure
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Diastolic Blood Pressure
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

Results and safety

Results posted to the registry on 9 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	43	39
Intervention Group	44	40

Primary outcome: PCSK-9 Level

Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program). Mean (Standard Deviation). Unit: ng/ml

Measure	Control Group n = 39	Intervention Group n = 40
Value	377.5 (118.9)	322.53 (107.5)

Population analysed: Patients who completed the cardiac rehabilitation program

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	1 of 43 (2.3%)	2 of 43 (4.7%)	0 of 43
Intervention Group	1 of 44 (2.3%)	0 of 44 (0%)	0 of 44

Limitations and caveats (from the sponsor): This study only investigated selected population of patients (post CABG patients) and cannot explain further the mechanism of reduced PCSK9 level by doing resistance training

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15121495Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.
Background: PubMed 21896934Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.
Results publication: PubMed 23414745Ghroubi S, Elleuch W, Abid L, Abdenadher M, Kammoun S, Elleuch MH. Effects of a low-intensity dynamic-resistance training protocol using an isokinetic dynamometer on muscular strength and aerobic capacity after coronary artery bypass grafting. Ann Phys Rehabil Med. 2013 Mar;56(2):85-101. doi: 10.1016/j.rehab.2012.10.006. Epub 2012 Dec 7.
Results publication: PubMed 23176104Busch JC, Lillou D, Wittig G, Bartsch P, Willemsen D, Oldridge N, Bjarnason-Wehrens B. Resistance and balance training improves functional capacity in very old participants attending cardiac rehabilitation after coronary bypass surgery. J Am Geriatr Soc. 2012 Dec;60(12):2270-6. doi: 10.1111/jgs.12030. Epub 2012 Nov 23.
Results publication: PubMed 26081791Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Aug 26.
Results publication: PubMed 23973703Urban D, Poss J, Bohm M, Laufs U. Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis. J Am Coll Cardiol. 2013 Oct 15;62(16):1401-8. doi: 10.1016/j.jacc.2013.07.056. Epub 2013 Aug 21.
Results publication: PubMed 18547466Kim HS, Wu Y, Lin SJ, Deerochanawong C, Zambahari R, Zhao L, Zhang Q, Yan P. Current status of cholesterol goal attainment after statin therapy among patients with hypercholesterolemia in Asian countries and region: the Return on Expenditure Achieved for Lipid Therapy in Asia (REALITY-Asia) study. Curr Med Res Opin. 2008 Jul;24(7):1951-63. doi: 10.1185/03007990802138731. Epub 2008 Jun 10.
Results publication: PubMed 23128163Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
Results publication: PubMed 16554528Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. doi: 10.1056/NEJMoa054013.
Results publication: PubMed 17080197Lagace TA, Curtis DE, Garuti R, McNutt MC, Park SW, Prather HB, Anderson NN, Ho YK, Hammer RE, Horton JD. Secreted PCSK9 decreases the number of LDL receptors in hepatocytes and in livers of parabiotic mice. J Clin Invest. 2006 Nov;116(11):2995-3005. doi: 10.1172/JCI29383.
Results publication: PubMed 17452316Zhang DW, Lagace TA, Garuti R, Zhao Z, McDonald M, Horton JD, Cohen JC, Hobbs HH. Binding of proprotein convertase subtilisin/kexin type 9 to epidermal growth factor-like repeat A of low density lipoprotein receptor decreases receptor recycling and increases degradation. J Biol Chem. 2007 Jun 22;282(25):18602-18612. doi: 10.1074/jbc.M702027200. Epub 2007 Apr 23.
Results publication: PubMed 23862065Wen S, Jadhav KS, Williamson DL, Rideout TC. Treadmill Exercise Training Modulates Hepatic Cholesterol Metabolism and Circulating PCSK9 Concentration in High-Fat-Fed Mice. J Lipids. 2013;2013:908048. doi: 10.1155/2013/908048. Epub 2013 Jun 19.
website of hospital where the study protocol will be heldLink provided by the sponsor.
website of educational institution inside the hospitalLink provided by the sponsor.
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.

Bambang Dwiputra, MD principal investigator

National Cardiovascular Center Harapan Kita

Questions about this trial

What is this clinical trial studying?

A study testing resistance training and aerobic training in people with Coronary Artery Disease, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.

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 3 inclusion and 4 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PCSK-9 Level (time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)). 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 NCT02674659, which also lists 27 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 21 Jan 2020.