A Study to Treat Patients Whose Chronic Angina Symptoms Are Not Relieved by Medication and Have an Area of the Heart That Cannot be Treated by Standard Therapies
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|ClinicalTrials.gov Identifier: NCT00215696|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 13, 2011
The primary purpose of this study is to determine whether treatment with an experimental gene therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of new blood vessels. This will be measured by testing whether participants are able to exercise longer without experiencing angina after treatment, as compared to before treatment.
Additionally, this study will collect information about any side effects that might be related to the treatment with the experimental therapy.
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Angina Pectoris||Genetic: BioBypass®||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA™-GUIDED/MYOSTAR™ Catheter in "No Option" Patients With Class II-IV Stable Angina|
|Study Start Date :||April 2005|
- Change from baseline in total exercise duration on exercise tolerance test (ETT, using the bicycle ergometry test protocol) at week 26.
- Change of reversible perfusion defect size in SPECT perfusion study at week 26
- Total exercise duration at weeks 12 and 52
- Time-to-onset of 1mm ST depression on ETT at weeks 12, 26, 52
- Peak rate-pressure product and maximal workload (in METS) during ETT at weeks 12, 26, 52
- CCS class at weeks 12, 26, 52
- Frequency of angina attacks at weeks 12, 26, 52
- Nitroglycerine consumption at weeks 12, 26, 52
- Results of Seattle angina questionnaire at weeks 12, 26, 52
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215696
|Cardiovascular Laboratory 2014, The Heart Center, University hospital Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Skejby Sygehus, Caridology Laboratory|
|Århus N, Denmark, DK-8200|
|Cardiac Catheterization Laboratories, Cardiology Department, Rabin Medical Center|
|Petah, Tikva, Israel, 49100|
|Principal Investigator:||Dr. Jens Kastrup||The Heart Center, University hospital Rigshospitalet|