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Lifestyle Modification for Coronary Artery Disease (Century Trial)
N/A
Waitlist Available
Led By K. Lance Gould, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women age ≥40
Subjects must be competent to provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years, 5 years and 10 years
Awards & highlights
Century Trial Summary
This trial is looking at whether a combined image-treatment regimen of PET + lifestyle modification and lipid-lowering drugs can improve cardiovascular risk score and potentially lower rate of death and other heart problems, compared to current standard of care.
Who is the study for?
The Century Trial is for men and women over 40 who may have or are at high risk of coronary artery disease (CAD). They should be able to consent, need stress perfusion testing, and could have diabetes, recent smoking history, unhealthy cholesterol levels, hypertension, or a family history of CAD. Excluded are those with severe kidney issues, recent heart attacks or strokes, morbid obesity, other major illnesses affecting survival chances or participation ability.Check my eligibility
What is being tested?
This Phase III trial tests if a comprehensive lifestyle modification program plus lipid-lowering drugs can improve cardiovascular health better than standard care. It measures the impact on death rates and heart events by comparing two groups: one receiving PET scans with the new therapy regimen and another following current medical guidelines.See study design
What are the potential side effects?
While specific side effects aren't listed for this lifestyle intervention study focused on diet and exercise improvements alongside medication adjustments for cholesterol management; potential side effects might include muscle pain from statins used in lipid control.
Century Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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I am mentally capable of understanding and signing a consent form.
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I am being tested for heart issues due to symptoms, a history of heart disease, or past heart surgery.
Century Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years, 5 years and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years, 5 years and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1.Clinical Endpoints-
Secondary outcome measures
2.
Other outcome measures
Comprehensive economic analysis
Century Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive lifestyle modificationExperimental Treatment1 Intervention
P.E.T. guided comprehensive therapy program. The study intervention is Comprehensive therapy program for risk factor modification. The Comprehensive program of atherosclerotic risk factor modification involves 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 primary physician. No experimental medications or procedures will be used.
Group II: Current standard of careActive Control1 Intervention
Current standard of care medical management as provided by primary physician.
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
319,892 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
6,824 Patients Enrolled for Coronary Artery Disease
K. Lance Gould, MDPrincipal InvestigatorUniversity of Texas Medical Health Science Center at Houston
1 Previous Clinical Trials
14 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
14 Patients Enrolled for Coronary Artery Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is severely reduced.I have experienced fast and irregular heartbeats.I have a severe disability that won't improve in 6 months, preventing me from exercising.I am 40 years old or older.I have had a heart attack in the last 4 weeks.You need to have a stress perfusion test for a specific medical reason.I am younger than 40 years old.I have had heart bypass or stent placement in the last 6 months.I have unstable angina with specific heart test changes.I have risk factors like diabetes, smoking, high LDL, low HDL, hypertension, or a family history of early heart disease.I experience chest pain, ranging from severe to mild.My kidney function is poor, with creatinine levels above 2.0 mg/dl.I am mentally capable of understanding and signing a consent form.You have a very high body mass index, which means you are extremely overweight.I have a heart valve condition.You have a low chance of having coronary artery disease, based on the criteria mentioned above.I have not had a stroke in the last 4 weeks.My liver functions are within normal limits.Your blood pressure is very high, with a systolic reading over 200 mmHg.I am being tested for heart issues due to symptoms, a history of heart disease, or past heart surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Intensive lifestyle modification
- Group 2: Current standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spaces available for enrolment in this clinical test?
"According to the clinicaltrials.gov database, this investigation is no longer soliciting participants. Initially published on March 11th 2009 and last updated May 20th 2022, there are 1,046 other trials actively recruiting patients today even though this one has concluded its recruitment phase."
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