AtherosclerosisPhase 4NCT02114697
Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
A Phase 4 study testing Statin therapy and Lifestyle modification in people with Atherosclerosis, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to assess a slimy substance that settles/deposits along blood vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various parts of body. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Statin therapy and Lifestyle modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2017
- Phase
- Phase 4
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 and above with prior head and neck or chest irradiation
- Six months or more post head and neck irradiation
- Documented subclinical cardiovascular disease (inflammatory markers in the serum)
- Pre-existing plaques (detected by ultrasound, CT or MRI)
- Asymptomatic major arterial stenosis
- Not being considered for arterial surgery or endovascular treatment.
Who cannot join
- Recurrence of cancer (with or without treatment)
- Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
- Renal failure
- Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum creatinine levels, race, age and gender)
- Medically unstable or hematologic, renal, or hepatic dysfunction
- Non-atherosclerotic arterial stenosis (dissection)
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- Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
- Contraindications to MRI: cardiac pacemaker, metal implants, metal in eyes, pregnant or nursing women, claustrophobia, allergy to MRI contrast
- Physical or mental impairment that would limit the patient's ability to comply with the medical instructions or study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess a slimy substance that settles/deposits along blood vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at risk of cardiovascular disease can have certain markers elevated in their blood that can be measured by simple blood tests.
High or increased plaque deposition is seen in neck vessels of cancer patients who received radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are at increased risk of plaque development and are therefore called high-risk population. Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are one of the several fat lowering medications.
Read the detailed description
Cardiovascular disease (CVD) and cancer are the leading causes of suffering and death amongst the American population. While an ever-increasing number of cancer survivors have a favorable outcome due to advances in cancer treatment; cancer survivors remain at high risk of developing CVD at an early age. There is scant information available on the pathogenic process that contributes to cardiovascular threat amongst cancer survivors and little is known about the interventions, which may interrupt or decrease the risk of CVD in this population. Importantly, early-subclinical markers may substantially precede clinical markers.
The objective of this project is to accurately determine the constituents and characteristics of atherosclerotic plaques in carotid arteries by magnetic resonance imaging (MRI) techniques in cancer survivors; at different data intervals: before and after administration of treatment (medical and life style modification) and then correlate contrast agent dynamics with serum markers of inflammation and other tests of cardiac or vascular dysfunction, where available.
The proposed study involves 100 asymptomatic patients who received prior chest or head and neck radiation therapy (HNXRT) as part of cancer treatment. MRI data (direct assessment of atherosclerosis) would be correlated with indirect measures of atherosclerosis (blood surrogate markers \& metabolomics).
The investigators intend to conduct an initial baseline MRI, blood tests (to correlate with surrogate markers of inflammation) and other tests whenever available of cardiac or vascular dysfunction. This cohort will be followed up with medication and/or life style modification regimen for a period of initially18 months and subsequently at 36 months. A repeat of all baseline studies (MRI and blood tests) would be performed as part of the 18 and 36-month follow-up. The plaque characteristics found at MRI will be correlated with results of blood tests (baseline, 18 and 36 months) and changes in one or both will be the expected end point of the study.
- Conditions
- Atherosclerosis
- Being tested
- Statin therapy, Lifestyle modification
- Keywords
- Cancer survivorship, Cardiovascular disease, Stroke, Transient ischemic attack (TIA)
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin therapyDrug
Also called Crestor
Statin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement.
Lifestyle modificationBehavioural
Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Active comparator | Lifestyle modification is tailored to each participant and includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake. Receives: Behavioral: Lifestyle modification |
| Statin therapy | Experimental | Participants will receive statin medication along with instruction about regular exercise. Receives: Drug: Statin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Volume of Carotid Arteries
Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.
Measured: Baseline, 18 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: The study was stopped when the original principal investigator moved to a new institution.
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 (34)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The protocol originally specified randomizing participants to a study arm, but the protocol was amended to clarify that a participant's cardiologist could change the treatment regimens that participants were assigned to so that no participant was restricted from statin therapy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Oshinski, Emory University
- Investigators
- John Oshinski, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114697
- Sponsor's protocol ID
- IRB00059784
- Status last verified
- Aug 2018
- First submitted
- 10 Apr 2014
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ota H, Yu W, Underhill HR, Oikawa M, Dong L, Zhao X, Polissar NL, Neradilek B, Gao T, Zhang Z, Yan Z, Guo M, Zhang Z, Hatsukami TS, Yuan C. Hemorrhage and large lipid-rich necrotic cores are independently associated with thin or ruptured fibrous caps: an in vivo 3T MRI study. Arterioscler Thromb Vasc Biol. 2009 Oct;29(10):1696-701. doi: 10.1161/ATVBAHA.109.192179. Epub 2009 Jul 16.
PubMed 19608971Virmani R, Burke AP, Kolodgie FD, Farb A. Vulnerable plaque: the pathology of unstable coronary lesions. J Interv Cardiol. 2002 Dec;15(6):439-46. doi: 10.1111/j.1540-8183.2002.tb01087.x.
PubMed 12476646Yeh JM, Nekhlyudov L, Goldie SJ, Mertens AC, Diller L. A model-based estimate of cumulative excess mortality in survivors of childhood cancer. Ann Intern Med. 2010 Apr 6;152(7):409-17, W131-8. doi: 10.7326/0003-4819-152-7-201004060-00005.
PubMed 20368646Dorresteijn LD, Kappelle AC, Boogerd W, Klokman WJ, Balm AJ, Keus RB, van Leeuwen FE, Bartelink H. Increased risk of ischemic stroke after radiotherapy on the neck in patients younger than 60 years. J Clin Oncol. 2002 Jan 1;20(1):282-8. doi: 10.1200/JCO.2002.20.1.282.
PubMed 11773180Jordan LC, Duffner PK. Early-onset stroke and cerebrovascular disease in adult survivors of childhood cancer. Neurology. 2009 Dec 1;73(22):1816-7. doi: 10.1212/WNL.0b013e3181c33b10. Epub 2009 Oct 21. No abstract available.
PubMed 19846829Diller L, Chow EJ, Gurney JG, Hudson MM, Kadin-Lottick NS, Kawashima TI, Leisenring WM, Meacham LR, Mertens AC, Mulrooney DA, Oeffinger KC, Packer RJ, Robison LL, Sklar CA. Chronic disease in the Childhood Cancer Survivor Study cohort: a review of published findings. J Clin Oncol. 2009 May 10;27(14):2339-55. doi: 10.1200/JCO.2008.21.1953. Epub 2009 Apr 13. No abstract available.
PubMed 19364955Mertens AC, Yasui Y, Neglia JP, Potter JD, Nesbit ME Jr, Ruccione K, Smithson WA, Robison LL. Late mortality experience in five-year survivors of childhood and adolescent cancer: the Childhood Cancer Survivor Study. J Clin Oncol. 2001 Jul 1;19(13):3163-72. doi: 10.1200/JCO.2001.19.13.3163.
PubMed 11432882Haynes JC, Machtay M, Weber RS, Weinstein GS, Chalian AA, Rosenthal DI. Relative risk of stroke in head and neck carcinoma patients treated with external cervical irradiation. Laryngoscope. 2002 Oct;112(10):1883-7. doi: 10.1097/00005537-200210000-00034.
PubMed 12368635Bowers DC, Liu Y, Leisenring W, McNeil E, Stovall M, Gurney JG, Robison LL, Packer RJ, Oeffinger KC. Late-occurring stroke among long-term survivors of childhood leukemia and brain tumors: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2006 Nov 20;24(33):5277-82. doi: 10.1200/JCO.2006.07.2884. Epub 2006 Nov 6.
PubMed 17088567Moser EC, Noordijk EM, van Leeuwen FE, le Cessie S, Baars JW, Thomas J, Carde P, Meerwaldt JH, van Glabbeke M, Kluin-Nelemans HC. Long-term risk of cardiovascular disease after treatment for aggressive non-Hodgkin lymphoma. Blood. 2006 Apr 1;107(7):2912-9. doi: 10.1182/blood-2005-08-3392. Epub 2005 Dec 8.
PubMed 16339404Steele SR, Martin MJ, Mullenix PS, Crawford JV, Cuadrado DS, Andersen CA. Focused high-risk population screening for carotid arterial stenosis after radiation therapy for head and neck cancer. Am J Surg. 2004 May;187(5):594-8. doi: 10.1016/j.amjsurg.2004.01.014.
PubMed 15135672Casscells W, Naghavi M, Willerson JT. Vulnerable atherosclerotic plaque: a multifocal disease. Circulation. 2003 Apr 29;107(16):2072-5. doi: 10.1161/01.CIR.0000069329.70061.68. No abstract available.
PubMed 12719287Hatsukami TS, Ross R, Polissar NL, Yuan C. Visualization of fibrous cap thickness and rupture in human atherosclerotic carotid plaque in vivo with high-resolution magnetic resonance imaging. Circulation. 2000 Aug 29;102(9):959-64. doi: 10.1161/01.cir.102.9.959.
PubMed 10961958MacNeill BD, Lowe HC, Takano M, Fuster V, Jang IK. Intravascular modalities for detection of vulnerable plaque: current status. Arterioscler Thromb Vasc Biol. 2003 Aug 1;23(8):1333-42. doi: 10.1161/01.ATV.0000080948.08888.BF. Epub 2003 Jun 12.
PubMed 12805071Crisby M, Nordin-Fredriksson G, Shah PK, Yano J, Zhu J, Nilsson J. Pravastatin treatment increases collagen content and decreases lipid content, inflammation, metalloproteinases, and cell death in human carotid plaques: implications for plaque stabilization. Circulation. 2001 Feb 20;103(7):926-33. doi: 10.1161/01.cir.103.7.926.
PubMed 11181465
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02114697
- Acronym / sponsor ID
- IRB00059784
- Conditions
- Atherosclerosis
- Keywords
- Cancer survivorship, Cardiovascular disease, Stroke, Transient ischemic attack (TIA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped when the original principal investigator moved to a new institution.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 14 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess a slimy substance that settles/deposits along blood vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at risk of cardiovascular disease can have certain markers elevated in their blood that can be measured by simple blood tests.
High or increased plaque deposition is seen in neck vessels of cancer patients who received radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are at increased risk of plaque development and are therefore called high-risk population. Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are one of the several fat lowering medications.
Detailed description
Cardiovascular disease (CVD) and cancer are the leading causes of suffering and death amongst the American population. While an ever-increasing number of cancer survivors have a favorable outcome due to advances in cancer treatment; cancer survivors remain at high risk of developing CVD at an early age. There is scant information available on the pathogenic process that contributes to cardiovascular threat amongst cancer survivors and little is known about the interventions, which may interrupt or decrease the risk of CVD in this population. Importantly, early-subclinical markers may substantially precede clinical markers.
The objective of this project is to accurately determine the constituents and characteristics of atherosclerotic plaques in carotid arteries by magnetic resonance imaging (MRI) techniques in cancer survivors; at different data intervals: before and after administration of treatment (medical and life style modification) and then correlate contrast agent dynamics with serum markers of inflammation and other tests of cardiac or vascular dysfunction, where available.
The proposed study involves 100 asymptomatic patients who received prior chest or head and neck radiation therapy (HNXRT) as part of cancer treatment. MRI data (direct assessment of atherosclerosis) would be correlated with indirect measures of atherosclerosis (blood surrogate markers \& metabolomics).
The investigators intend to conduct an initial baseline MRI, blood tests (to correlate with surrogate markers of inflammation) and other tests whenever available of cardiac or vascular dysfunction. This cohort will be followed up with medication and/or life style modification regimen for a period of initially18 months and subsequently at 36 months. A repeat of all baseline studies (MRI and blood tests) would be performed as part of the 18 and 36-month follow-up. The plaque characteristics found at MRI will be correlated with results of blood tests (baseline, 18 and 36 months) and changes in one or both will be the expected end point of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The protocol originally specified randomizing participants to a study arm, but the protocol was amended to clarify that a participant's cardiologist could change the treatment regimens that participants were assigned to so that no participant was restricted from statin therapy.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Active comparator | Behavioral: Lifestyle modificationLifestyle modification is tailored to each participant and includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake. |
| Statin therapy | Experimental | Drug: Statin therapyParticipants will receive statin medication along with instruction about regular exercise. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 22 and above with prior head and neck or chest irradiation
- Six months or more post head and neck irradiation
- Documented subclinical cardiovascular disease (inflammatory markers in the serum)
- Pre-existing plaques (detected by ultrasound, CT or MRI)
- Asymptomatic major arterial stenosis
Key exclusion criteria (9 listed)
- Recurrence of cancer (with or without treatment)
- Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
- Renal failure
- Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum creatinine levels, race, age and gender)
- Medically unstable or hematologic, renal, or hepatic dysfunction
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 |
|---|---|---|
| Statin therapyAlso: CrestorStatin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement. | Drug | Statin therapy |
| Lifestyle modificationLifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years. | Behavioural | Lifestyle modification |
Primary outcome
Plaque Volume of Carotid Arteries
Time frame: Baseline, 18 months, 36 months
Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19608971Ota H, Yu W, Underhill HR, Oikawa M, Dong L, Zhao X, Polissar NL, Neradilek B, Gao T, Zhang Z, Yan Z, Guo M, Zhang Z, Hatsukami TS, Yuan C. Hemorrhage and large lipid-rich necrotic cores are independently associated with thin or ruptured fibrous caps: an in vivo 3T MRI study. Arterioscler Thromb Vasc Biol. 2009 Oct;29(10):1696-701. doi: 10.1161/ATVBAHA.109.192179. Epub 2009 Jul 16.
- Background: PubMed 12476646Virmani R, Burke AP, Kolodgie FD, Farb A. Vulnerable plaque: the pathology of unstable coronary lesions. J Interv Cardiol. 2002 Dec;15(6):439-46. doi: 10.1111/j.1540-8183.2002.tb01087.x.
- Background: PubMed 20368646Yeh JM, Nekhlyudov L, Goldie SJ, Mertens AC, Diller L. A model-based estimate of cumulative excess mortality in survivors of childhood cancer. Ann Intern Med. 2010 Apr 6;152(7):409-17, W131-8. doi: 10.7326/0003-4819-152-7-201004060-00005.
- Background: PubMed 11773180Dorresteijn LD, Kappelle AC, Boogerd W, Klokman WJ, Balm AJ, Keus RB, van Leeuwen FE, Bartelink H. Increased risk of ischemic stroke after radiotherapy on the neck in patients younger than 60 years. J Clin Oncol. 2002 Jan 1;20(1):282-8. doi: 10.1200/JCO.2002.20.1.282.
- Background: PubMed 19846829Jordan LC, Duffner PK. Early-onset stroke and cerebrovascular disease in adult survivors of childhood cancer. Neurology. 2009 Dec 1;73(22):1816-7. doi: 10.1212/WNL.0b013e3181c33b10. Epub 2009 Oct 21. No abstract available.
- Background: PubMed 19364955Diller L, Chow EJ, Gurney JG, Hudson MM, Kadin-Lottick NS, Kawashima TI, Leisenring WM, Meacham LR, Mertens AC, Mulrooney DA, Oeffinger KC, Packer RJ, Robison LL, Sklar CA. Chronic disease in the Childhood Cancer Survivor Study cohort: a review of published findings. J Clin Oncol. 2009 May 10;27(14):2339-55. doi: 10.1200/JCO.2008.21.1953. Epub 2009 Apr 13. No abstract available.
- Background: PubMed 11432882Mertens AC, Yasui Y, Neglia JP, Potter JD, Nesbit ME Jr, Ruccione K, Smithson WA, Robison LL. Late mortality experience in five-year survivors of childhood and adolescent cancer: the Childhood Cancer Survivor Study. J Clin Oncol. 2001 Jul 1;19(13):3163-72. doi: 10.1200/JCO.2001.19.13.3163.
- Background: PubMed 12368635Haynes JC, Machtay M, Weber RS, Weinstein GS, Chalian AA, Rosenthal DI. Relative risk of stroke in head and neck carcinoma patients treated with external cervical irradiation. Laryngoscope. 2002 Oct;112(10):1883-7. doi: 10.1097/00005537-200210000-00034.
- Background: PubMed 17088567Bowers DC, Liu Y, Leisenring W, McNeil E, Stovall M, Gurney JG, Robison LL, Packer RJ, Oeffinger KC. Late-occurring stroke among long-term survivors of childhood leukemia and brain tumors: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2006 Nov 20;24(33):5277-82. doi: 10.1200/JCO.2006.07.2884. Epub 2006 Nov 6.
- Background: PubMed 16339404Moser EC, Noordijk EM, van Leeuwen FE, le Cessie S, Baars JW, Thomas J, Carde P, Meerwaldt JH, van Glabbeke M, Kluin-Nelemans HC. Long-term risk of cardiovascular disease after treatment for aggressive non-Hodgkin lymphoma. Blood. 2006 Apr 1;107(7):2912-9. doi: 10.1182/blood-2005-08-3392. Epub 2005 Dec 8.
- Background: PubMed 15135672Steele SR, Martin MJ, Mullenix PS, Crawford JV, Cuadrado DS, Andersen CA. Focused high-risk population screening for carotid arterial stenosis after radiation therapy for head and neck cancer. Am J Surg. 2004 May;187(5):594-8. doi: 10.1016/j.amjsurg.2004.01.014.
- Background: PubMed 12719287Casscells W, Naghavi M, Willerson JT. Vulnerable atherosclerotic plaque: a multifocal disease. Circulation. 2003 Apr 29;107(16):2072-5. doi: 10.1161/01.CIR.0000069329.70061.68. No abstract available.
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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.
John Oshinski, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Statin therapy and Lifestyle modification in people with Atherosclerosis, run by Emory University 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 6 inclusion and 9 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 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2018). 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?
Plaque Volume of Carotid Arteries (time frame: Baseline, 18 months, 36 months). 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 NCT02114697, which also lists 34 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 11 Sep 2018.