Treatment for Coronary Artery Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Lexington VA Medical Center, Lexington, KY
Coronary Artery Disease+5 More
Eligibility
18+
All Sexes
Eligible conditions
Coronary Artery Disease

Study Summary

This study is evaluating whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable

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Eligible Conditions

  • Coronary Artery Disease
  • Heart Diseases
  • Cardiovascular Diseases
  • Myocardial Ischemia
  • Ischemia
  • Coronary Disease

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 12 primary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of 5 years.

3.2 year follow-up (median)
Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
5 years
Cumulative Event Rate of Death From Any Cause
Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
Cumulative Event Rate of Myocardial Infarction
Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
Number of Participants That Experienced Death From Any Cause
Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
Number of Participants That Experienced Myocardial Infarction

Trial Safety

Trial Design

2 Treatment Groups

Conservative Strategy

This trial requires 5179 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Conservative StrategyOptimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Invasive Strategy (INV)Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3.2 year follow-up (median)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3.2 year follow-up (median) for reporting.

Closest Location

Lexington VA Medical Center - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least moderate ischemia on a qualifying stress test
Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
Participant is willing to give written informed consent
Age ≥ 21 years

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get coronary artery disease a year in the United States?

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In the U.S. as of 2006, approximately 8.1 million Americans have CAD, with approximately 1 million new cases occurring each year. About 15% of men and 26% of women are diagnosed with CAD. Those with diabetes have a higher lifetime risk for CAD than those without diabetes.

Unverified Answer

What are the signs of coronary artery disease?

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Signs of CAD may include chest pain, shortness of breath with exercise, increased heart rate, arrhythmias and palpitations. These symptoms are often un-specific in people who are otherwise healthy. There are also signs which may suggest CAD (unspecified risk factors) but which do not always indicate disease. Specific tests may also be necessary.

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Can coronary artery disease be cured?

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As the number of patients included in clinical trials decreases, a more serious doubt may be raised against the possible superiority of the newest treatments and procedures. Therefore, the results of our study have to be taken into consideration.

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What is coronary artery disease?

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Many patients with chest pain have significant CAD, and many others will never get a heart attack or suffer a myocardial infarction. Patients in the high-risk group for CAD should receive coronary artery angiography, regardless of the presenting complaint.

Unverified Answer

What causes coronary artery disease?

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Genetic, hormonal, and environmental factors such as obesity and high blood pressure all have a causal role in developing coronary artery disease, but also other less known factors such as high cholesterol and diabetes are important contributors to the risk of developing atherosclerosis and CAD.

Unverified Answer

What are common treatments for coronary artery disease?

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Statins are the first-line treatment for lipid abnormalities in coronary artery disease, which are independent risk factors for disease progression and recurrence. Statin use is also associated with a decreased risk of heart attack and stroke; however, the risks can be increased at the initiation of treatment and during switching from one statin to another. Evidence supports the use of beta blockers as an adjunct to statins for reducing the risk of cardiovascular events. The use of antiplatelet agents may reduce the risk of cardiovascular events. Angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor antagonists (ARAs) reduce blood pressure and are thought to be able to slow the progression of the disease.

Unverified Answer

What are the common side effects of treatment?

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While all treatments will cause a number of side effects, the overall list is long and varied and can include most commonly [fecal urgency, constipation, dizziness, drowsiness] and rarely [anxiety, nausea, rash, numbness in hand, blurred vision]. When prescribing treatments, [Power®] can help with selecting a treatment option that avoids and minimizes the most common side effects. [Power®] can also be used to assess side effects prior to initiating treatment. You can also ask your doctor to check with their prescribing team. You can also search [Side Effects Reports | SERS] for your treatment options so that you can avoid or minimize the side effects associated with [SERS] treatments.

Unverified Answer

Is treatment safe for people?

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Treatment of coronary artery disease in women is more risky than in men. However, treatment in women does not have a higher risk of major adverse events than treatment in men; in both groups, treatment appears to be safe.

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Who should consider clinical trials for coronary artery disease?

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Physicians are increasingly recommending IHD clinical trial participation for most patients. For patients who present with signs of ischemia they may want to have more data on their condition, have [coronary artery disease (CAD)] and have more information provided. However, our study showed that for most patients, CAD clinical trial participation is not recommended.

Unverified Answer

What is the primary cause of coronary artery disease?

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In a contemporary sample of myocardial infarction survivors, about 1 in 4 men and 1 in 3 women had diabetes mellitus. In men, diabetes was correlated with a more rapid progression of atherosclerosis. In women, diabetes was associated with a higher frequency of non-fatal stroke-suspected coronary artery stenosis.

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Has treatment proven to be more effective than a placebo?

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Although further study is needed, this meta-analysis shows that treatment is more effective than a placebo to reduce cardiovascular risk factors and reduce the chance of a future cardiac or stroke event.

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How serious can coronary artery disease be?

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This is the most significant complication of severe CAS and, as a result, must be managed aggressively. The presence of both the major and minor causes of early, late, and in-hospital death are important but do not always add up to a final death rate to guide clinical trial design.

Unverified Answer
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