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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

Must not have

Left ventricular ejection fraction (LVEF) <30%

Symptomatic sustained or non-sustained ventricular tachycardia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years, 5 years and 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is severely reduced.

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I have experienced fast and irregular heartbeats.

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I have a severe disability that won't improve in 6 months, preventing me from exercising.

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I am younger than 40 years old.

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I have unstable angina with specific heart test changes.

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My kidney function is poor, with creatinine levels above 2.0 mg/dl.

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I have a heart valve condition.

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My liver functions are within normal limits.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years, 5 years and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1.Clinical Endpoints-

Secondary study objectives

Other study objectives

Comprehensive economic analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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