CLINICAL TRIAL

Treatment for Coronary Artery Disease

Waitlist Available · 18+ · All Sexes · San Diego, CA

This study is evaluating whether a new type of stent may help improve blood flow in the heart.

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About the trial for Coronary Artery Disease

Eligible Conditions
ST Elevation Myocardial Infarction · ST Segment Elevation Myocardial Infarction (STEMI) · Coronary Stenosis · Infarction · Atherosclerosis · Coronary Artery Disease · Non ST Segment Elevation Myocardial Infarction (NSTEMI) · Myocardial Infarction

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.

Control Group 1
Coronary PCI guided by OCT
DEVICE
Control Group 2
Coronary PCI guided by Angiography
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Inclusion Criteria (all must be present)
Subject must be at least 18 years of age.
Subjects must have evidence of myocardial ischemia (e.g. show original
A) High clinical-risk, defined as;
i. Medication-treated diabetes mellitus, AND/OR B) High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;
You have a STEMI and you are hospitalized within 24 hours of the onset of symptoms. show original
You have a total lesion length of 28 mm or more in any single target vessel. show original
For a long target lesion, this would permit treatment by a single long stent or overlapping stents. show original
iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the main branch and side branch), and where the planned side branch stent is ≥ 2.5 mm in diameter by angiographic visual estimation.
For up to two target lesions located in a single target vessel and treated with non-overlapping stents, they may be located in a continuous vessel or split up between a main vessel and a side branch. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: At 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 4 primary outcomes, 50 secondary outcomes, and 58 other outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours.

Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Performance of atherectomy
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Performance of atherectomy (site reported; assessed per subject; OCT Arm Only)
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of additional inflations
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Use of additional inflations (site reported; assessed per subject; OCT Arm Only)
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of higher inflation pressures
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Use of higher inflation pressures (site reported; assessed per subject; OCT Arm Only)
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Procedural complications
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Defined as A) angiographic core laboratory-assessed complications listed in 10(vi) above occurring anytime during the procedure; or B) site-assessed prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, or procedural death
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Device Usage - Post dilatation
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Post dilatation (yes/no) (site reported; assessed per subject)
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Contrast use
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
Contrast induced nephropathy (defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL); need for renal replacement therapy
TIME OF PCI PROCEDURE - PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 24 HOURS
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Patient Q & A Section

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

What are the signs of coronary artery disease?

Signs of coronary artery disease may include chest pain, cough and shortness of breath. Coronary artery disease (CAD) can develop late, and signs of coronary artery disease may include chest pain, cough and shortness of breath. Cardiac stress test is the most effective method to determine the need for coronary artery bypass surgery (CABG).

Anonymous Patient Answer

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

Among those who die from coronary disease by age 85, the projected lifetime risks for men under age 65 is 7%; for the 25-age-to-85 subgroup, the risks are 24%. Among women at the same age, the lifetime risks are 13% and 30%, respectively.

Anonymous Patient Answer

What is coronary artery disease?

Cardiovascular problems, which have increased in importance and frequency in industrialized nations, are largely caused by the buildup of plaque in the coronary arteries. These plaques then may rupture, forming the emboli that can compromise the heart's ability to pump blood and may ultimately result in atherosclerosis of the heart's blood vessels. There are five clinically significant categories of diseases of the coronary artery:\n1. Atherosclerosis (hardening of the arteries due to their contents, e.g., cholesterol) - common, with one-third of men affected\n2.

Anonymous Patient Answer

Can coronary artery disease be cured?

Although not conclusive due to the short follow-up time, the mortality rate for all of the treated patients was significantly lower than in a matched control group of patients with symptomatic angina which did not receive revascularization, but that does not necessarily prove that angioplasty offers a survival advantage. The current limitations in this study include the retrospective review of patients and the limitations of the study itself.

Anonymous Patient Answer

What are common treatments for coronary artery disease?

While only 9% of US adults have significant CAD, the percentage of those who are treated with revascularization varies considerably between regions. In addition, there often are significant differences in the rates of angioplasty and revascularization by race and ethnicity.

Anonymous Patient Answer

What causes coronary artery disease?

Over 60 genetic factors may explain about half of cases. Inheritance contributes to less than 10%. The greatest risk is to men in their 50s, most of whom have one affected first-degree relative (FDR).

Anonymous Patient Answer

How does treatment work?

For a patient presenting with a history of angina who is being considered for revascularization, the results from this study have shown that, in the subgroup of patients who received pravastatin, there was a better overall health status and improvement in angina symptoms during follow-up.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

In the past 12 months, there were only three new large trials, involving 2 new treatments that met the criteria of this study. Thus, the numbers of participants included in clinical trials in which the treatment was not a standard treatment but rather an experimental treatment are low. Nevertheless, there are new treatments currently undergoing phase II and III clinical studies, including drugs that lower cholesterol, and some that target other autoimmune diseases (e.g., rituximab). This article discusses and presents a review of the available research articles.

Anonymous Patient Answer

What is treatment?

The definition of treatment for cardiovascular disease is often vague and non-standardized. As such, the terms therapy, medication, intervention, and prevention are used somewhat interchangeably, which may lead some clinicians to misinterpret an intervention as treatment. What matters most to patients and clinicians is the choice of treatment. This is not just based on efficacy or safety profiles, but must acknowledge patients' preferences and the fact that there is no standard definition of treatments.

Anonymous Patient Answer

What is the primary cause of coronary artery disease?

Patients with atherosclerosis are younger (mean 67 vs. 62, p=0.003), have more female sex (55% female vs. 49%, p=0.002), have more CAD (40% vs. 27%, p=0.02), and more obesity (39% vs. 23%, p=0.01) than patients without atherosclerosis.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

Recent advances in revascularization and percutaneous vessel closure can improve the treatment options. Therapeutic angioplasty and percutaneous vessel closure should be performed if the patients present with symptomatic patients with severe angina pectoris.

Anonymous Patient Answer

Does treatment improve quality of life for those with coronary artery disease?

Treatment with statins alters HRQoL. HRQoL is associated with an adverse risk profile. Results from a recent paper may help clinicians address unmet patient-centered needs.

Anonymous Patient Answer
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