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Gene Therapy
Gene Therapy for Angina (AWARE Trial)
Phase 3
Waitlist Available
Research Sponsored by Cardium Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients 18-75 years of age inclusive
Stable angina classified as CCS III or IV
Must not have
Clinically significant aortic or mitral valvular heart disease
History of cancer, other than basal cell carcinoma, or patients with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Who is the study for?
This trial is for women aged 18-75 with stable angina (CCS III or IV) who can't have standard heart vessel procedures. They must be on maximum doses of at least two anti-anginal medications, have a left ventricular ejection fraction of ≥30%, and show signs of heart stress during exercise tests.
What is being tested?
The study is testing Ad5FGF-4, a one-time gene therapy given directly to the heart vessels, against a placebo. It aims to see if this treatment can improve blood flow in the heart and reduce chest pain during exercise, as well as enhance overall quality of life.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with intracoronary infusions such as allergic reactions, infection risk at the catheter site, bleeding or clotting issues. Long-term safety will also be evaluated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 75.
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My chest pain is severe and limits my daily activities.
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I am on the highest doses of two different heart pain medications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious heart valve problem.
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I have had cancer before, but not basal cell carcinoma or any current cancer signs.
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I have severe eye problems due to diabetes or other causes.
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I have not taken part in any drug trials within the last 30 days.
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I have a history of low platelet counts due to a medical condition.
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I need surgery or a procedure to improve blood flow to my heart soon.
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I have had a heart attack in the last 3 months.
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I have inflammation of the heart muscle or tightness around my heart.
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I have severe heart rhythm problems that haven't been treated.
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I have a blockage near the heart's artery opening that prevents proper catheter use.
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I am immunosuppressed or take drugs that weaken my immune system.
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My heart condition severely limits my physical activity.
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My family has a history of genetic cancer.
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I do not have a major organ disease that significantly shortens my life.
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A close family member has had breast cancer.
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I have not had any heart-related gene or stem cell treatments.
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My heart's arteries are directly connected to veins, skipping the smallest blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
Group II: 1Experimental Treatment1 Intervention
Group III: 3Placebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Cardium TherapeuticsLead Sponsor
4 Previous Clinical Trials
667 Total Patients Enrolled
Robert Engler, MDStudy DirectorCardium Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
- Group 3: 3
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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