The PRECISE cardiac clinical trial was designed by a team of world renowned cardiac researchers, including Dr. Emerson Perin from Texas Heart Institute and Dr. Francisco Fernandez-Aviles. It examined the safety and feasibility of adipose-derived stem and regenerative cells (ADRCs) in the treatment of those with severe coronary artery diseaseHeart disease caused by plaque having built up in the arteries..
The 18 month study showed that treating patients with chronic coronary artery disease with ADRCsAdipose-derived stem and regenerative cells:
The two key measures of heart function are:
Patients who received stem cell therapy in the cardiac clinical trial showed
In the PRECISE trial, one of the most important findings was the improvement in MVO2. The MVO2 levels define a measure of how efficiently the body’s tissue utilizes oxygen.
18 months after treatment:
A patient with MVO2 of 14 or less has a 53% risk of dying within 12 months. The data suggests an MVO2 of 16 or greater suggests a lower risk of cardiac-related death.
A MET (Metabolic Equivalent of Task) score describes the amount of energy required to carry out a task. A MET score is a strong predictor of cardiac-related adverse events as well as mortality.
The PRECISE study population had a MET score of approximately 5, which put them at high risk in the near term. Eighteen months after treatment:
Infarct is the dead tissue tissue that results from the interruption of blood flow to the heart. Infarct size is also a strong predictor of patient mortality and adverse cardiac-related events.
The PRECISE trial also demonstrated a statistically significant improvement in infarct size in the heart. Infarct size is also a strong predictor of patient mortality and adverse cardiac-related events.
The PRECISE study recruited patients with chronic myocardial ischemia, a severe form of coronary artery disease.
In order to function properly, the heart needs an adequate blood supply. In those patients with chronic myocardial ischemiaChronic Myocardial Ischemia or CMI is another term for chronic coronary artery disease, blood flow to the heart has been compromised for years. This weakens the heart muscle and leads to heart failure.
In the PRECISE study:
One third of the patients did not receive an injection of cells but rather a placebo, an inactive substance with no effect on the heart. This group of patients is the control group. They allow researchers to show, by comparison, if the injection of stem cells in the cardiac clinical trial is effective.
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Aerobic capacity can be measured using the MVO2 test. MVO2 is the greatest amount of oxygen that a person can use in one minute. In order to use oxygen, it must be inhaled, transported around the body and used in metabolism. Thus, a high MVO2 number reflects a healthy heart, strong lungs and open blood vessels.
It is measured by looking at how well a person can tolerate exercise on a treadmill. This exercise is carried out while breathing into a respirometer mouthpiece. The treadmill gets faster until the subject can no longer carry on. The MVO2 is calculated by the respirometer.
When a person sits quietly, they use about 1 MET of energy. However, a person weighing 210 lbs will burn more calories than an individual weighing 110 lbs. The formula for calculating MET Score allows for differences in size so people can be fairly compared.
METS are also measured by testing a person on a treadmill. Running will generally produce an energy expenditure of 7 to 10 METS. If someone can do ten METS on a treadmill, they are in excellent condition. Patients that can do only five METS or less typically have a high incidence of adverse cardiac-related events in the near future.