Ignite Creation Date:
2024-05-05 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00756379
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-22
First Post:
2008-09-18
Brief Title:
Century Trial a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Randomized Trial of Comprehensive Lifestyle Modifications Optimal Pharmacological Treatment and PET Imaging for Detection and Management of Stable Coronary Artery Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Century
Brief Summary:
The Century Trial is a single center Phase III randomized study sponsored by the Albert Weatherhead III Foundation and conducted by Dr K Lance Gould The study hypothesis is that a combined image-treatment regimen of PET comprehensive program of lifestyle modification and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk score when compared to current standard optimal medical therapy potentially resulting in a lower rate of death non-fatal myocardial infarction MI and revascularization procedures during long term follow-up when compared with current standard of care If our hypothesis is correct we will not only improve our ability to prevent and treat CAD but we will also illustrate that even with the expenses of behavioral interventions and imaging techniques we can be very cost effective This information may help patients at risk or with known CAD to obtain insurance coverage to prevent the disease as well as providing a more effective way of treating it
Detailed Description:
Advances in diagnostic imaging with expensive technologies and reimbursement policies that favor illness intervention rather than primary and secondary prevention have resulted in rising costs of health care and more people being deprived of its benefits Sultz 2004 Bodenheimer 2002
In the field of coronary artery disease CAD are several non-invasive imaging techniques for diagnostic and risk stratification purposes such as echocardiography perfusion imaging cardiac stress SPECT - single photon emission computed tomography - and stress PET - positron emission tomography non-invasive cardiac computed tomography angiography CTA and combined perfusion-anatomy PET-CT studies There are an estimated 40 million noninvasive cardiac tests performed each year Mark DB 2003 For echocardiography and SPECT imaging reimbursement from Medicare encompasses approximately 30 of all payments totaling over 1 billion in the year 2000 ACC 2003 There are however basic questions about cardiovascular imaging techniques that need to be addressed how does technology benefit the patient It is worth the cost Is treatment plan enhanced Is outcome better Data are necessary for addressing these questions and if appropriate for acceptance among practicing physicians patients and third party insurers
The relevance of the proposed study the CENTURY trial lies in its original design testing the impact of stress perfusion imaging by PET coupled with two different intensities of clinical management strategies standard or comprehensive respectively This study will examine post-test resource utilization and reduction of cardiovascular risk in patients with known disease or at high risk for CAD
There will be a total of 1300 men and women enrolled with approximately 650 subjects randomized to one of two treatment arms Eligible patients must have clinical indications for stress perfusion testing
Following confirmation of eligibility and provision of signed informed consent patients will be randomized to one of the two possible treatment strategies At time of randomization patients will be assigned to PET guided comprehensive versus standard medical treatment
Patients of both groups will have a baseline myocardial PET perfusion study to quantify the blood flow to the heart muscle an electrocardiogram an exercise treadmill stress test to assess exercise tolerance fitness a thorough review of the quality of their diet and a complete blood work covering individual lipid profiles These tests and assessments will be repeated at 2 years and at 5 years
In addition subjects assigned to the standard medical management arm will be managed by current standard care provided by their primary referring physician and will be asked to come for clinic study visits annually for 5 years to document their medical and lifestyle management The PET scan results will be blinded until the end of the study to the standard of care management group
Subjects enrolled in the comprehensive medical management arm will have the support of a team of professionals focusing on atherosclerotic risk factor modification that involves recommended treatment to target lipid levels blood pressure and diabetes control smoking cessation very low fat diet and aerobic exercise program This is in addition to standard current medical therapy as provided by the primary referring physician
No experimental medication or procedures will be used Clinic visits for subjects education and consulting in the comprehensive program will be performed five times during the first year and semiannually thereafter
At the end of the first 5 years patients in the comprehensive medical management arm will be offered an additional 5-year follow-up at the current study location once a year
The extended follow-up on cardiovascular or other adverse events for the current standard of care group will be based on yearly telephone or mail follow-up
Both groups will have a full consultation visit exercise treadmill and dipyridamole PET scan at the end of the total 10 years follow-up replicating the current initial 5-year follow-up visit protocol
In the field of coronary artery disease CAD are several non-invasive imaging techniques for diagnostic and risk stratification purposes such as echocardiography perfusion imaging cardiac stress SPECT - single photon emission computed tomography - and stress PET - positron emission tomography non-invasive cardiac computed tomography angiography CTA and combined perfusion-anatomy PET-CT studies There are an estimated 40 million noninvasive cardiac tests performed each year Mark DB 2003 For echocardiography and SPECT imaging reimbursement from Medicare encompasses approximately 30 of all payments totaling over 1 billion in the year 2000 ACC 2003 There are however basic questions about cardiovascular imaging techniques that need to be addressed how does technology benefit the patient It is worth the cost Is treatment plan enhanced Is outcome better Data are necessary for addressing these questions and if appropriate for acceptance among practicing physicians patients and third party insurers
The relevance of the proposed study the CENTURY trial lies in its original design testing the impact of stress perfusion imaging by PET coupled with two different intensities of clinical management strategies standard or comprehensive respectively This study will examine post-test resource utilization and reduction of cardiovascular risk in patients with known disease or at high risk for CAD
There will be a total of 1300 men and women enrolled with approximately 650 subjects randomized to one of two treatment arms Eligible patients must have clinical indications for stress perfusion testing
Following confirmation of eligibility and provision of signed informed consent patients will be randomized to one of the two possible treatment strategies At time of randomization patients will be assigned to PET guided comprehensive versus standard medical treatment
Patients of both groups will have a baseline myocardial PET perfusion study to quantify the blood flow to the heart muscle an electrocardiogram an exercise treadmill stress test to assess exercise tolerance fitness a thorough review of the quality of their diet and a complete blood work covering individual lipid profiles These tests and assessments will be repeated at 2 years and at 5 years
In addition subjects assigned to the standard medical management arm will be managed by current standard care provided by their primary referring physician and will be asked to come for clinic study visits annually for 5 years to document their medical and lifestyle management The PET scan results will be blinded until the end of the study to the standard of care management group
Subjects enrolled in the comprehensive medical management arm will have the support of a team of professionals focusing on atherosclerotic risk factor modification that involves recommended treatment to target lipid levels blood pressure and diabetes control smoking cessation very low fat diet and aerobic exercise program This is in addition to standard current medical therapy as provided by the primary referring physician
No experimental medication or procedures will be used Clinic visits for subjects education and consulting in the comprehensive program will be performed five times during the first year and semiannually thereafter
At the end of the first 5 years patients in the comprehensive medical management arm will be offered an additional 5-year follow-up at the current study location once a year
The extended follow-up on cardiovascular or other adverse events for the current standard of care group will be based on yearly telephone or mail follow-up
Both groups will have a full consultation visit exercise treadmill and dipyridamole PET scan at the end of the total 10 years follow-up replicating the current initial 5-year follow-up visit protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None