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Gene Therapy for Angina (AWARE Trial)
AWARE Trial Summary
This trial will test whether a one-time infusion of a gene therapy can reduce the time to onset of myocardial ischemia and improve blood flow in the heart. Exercise capacity, patient symptoms, and quality of life will also be evaluated.
AWARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAWARE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AWARE Trial Design
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Who is running the clinical trial?
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- I have a serious heart valve problem.A heart specialist confirmed standard heart procedures won't work for me.I am a woman aged between 18 and 75.You are able to perform an exercise tolerance test using a specific method called the modified Bruce protocol.Your heart shows signs of reduced blood flow during the first 10 minutes of exercise.I have had cancer before, but not basal cell carcinoma or any current cancer signs.I have severe eye problems due to diabetes or other causes.You have tested positive for hepatitis B or C.I have not taken part in any drug trials within the last 30 days.I have a history of low platelet counts due to a medical condition.I have not had EECP treatment in the last 3 months.You have a specific heart condition called stress-induced myocardial ischemia, which can be detected through a medical imaging test.I need surgery or a procedure to improve blood flow to my heart soon.I have had a heart attack in the last 3 months.I have inflammation of the heart muscle or tightness around my heart.I have severe blockage in my heart's main or major arteries.I have severe heart rhythm problems that haven't been treated.I have a blockage near the heart's artery opening that prevents proper catheter use.My chest pain is severe and limits my daily activities.You have had a severe allergic reaction to contrast dye in the past.I had bypass surgery less than 6 months ago, but my grafts are not blocked.You have tested positive for HIV.I am immunosuppressed or take drugs that weaken my immune system.Your blood test shows high levels of creatinine, a substance that measures kidney function.My heart condition severely limits my physical activity.My family has a history of genetic cancer.I do not have a major organ disease that significantly shortens my life.A close family member has had breast cancer.Your SGPT level is more than double the normal range.I have not had any heart-related gene or stem cell treatments.I haven't been hospitalized for chest pain or needed IV heart medication in the last 2 weeks.I have not had laser heart surgery in the last year.Your white blood cell count is less than 3,000 per microliter.Your bilirubin level is 2.0 mg/dL or higher.I have no health issues that prevent me from doing a strenuous exercise test.Your heart's pumping ability, measured as LVEF, is at least 30%.Your parent, sibling, or child has had colon cancer, unless you had a colonoscopy in the last 36 months with normal results.Your heart's response to exercise is consistent and shows signs of possible heart problems within a certain timeframe.Your blood platelet count is less than 100,000 per microliter.Your electrocardiogram shows certain heart conditions that make it hard to check for exercise-related heart problems.I had a procedure to open my blood vessels less than 3 months ago, unless those vessels are now blocked.I am on the highest doses of two different heart pain medications.My heart's arteries are directly connected to veins, skipping the smallest blood vessels.
- Group 1: 1
- Group 2: 2
- Group 3: 3
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there several clinics running this study in the nation?
"This trial is being conducted at South Texas Cardiovascular Consultants in San Antonio, Texas, Fox Valley Cardiovascular Consultants in Aurora, Illinois, Creighton University in Omaha, Nebraska, as well as 47 other locations."
Are there any available positions for subjects in this research?
"Unfortunately, this particular clinical trial is not recruiting patients right now. The original posting was on May 1st, 2007, and there have been no updates since February 11th, 2013. There are, however, 53 other trials that are still recruiting patients."
Is this research being conducted with elderly individuals?
"The age limit to be a part of this particular trial is 75. If an applicant is under 18, there are 3 other trials they could be eligible for. If they are over 65, there are 53 other trials."
For whom is this drug testing program seeking participants?
"This study, which is looking for 300 participants, needs patients that have angina pectoris and meet the following additional requirements: be within the ages of 18 and 75, currently receiving treatment with two different classes of chronic anti-anginal medication (both at maximally tolerated doses), be female, able to undergo ETT, have ECG changes that are diagnostic of myocardial ischemia during the first 10 minutes of exercise, have variability of the time to onset of ECG changes that is ≤25% or within 60 seconds if the time to onset of myocardial ischemia occurs within the first 4 minutes of exercise"
Is there a potential for Ad5FGF-4 to be harmful to human subjects?
"Ad5FGF-4's safety is estimated to be a 3. This is due to this being a Phase 3 trial, meaning that there is efficacy data as well as multiple rounds of safety data."
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