New treatment may prevent disability in stroke patients

Enrique Chapa lay in a hospital emergency room bed about a month ago, disoriented, unable to speak and barely able to move. Paramedics had just rushed in the 75-year-old retired truck driver, who had suffered a major stroke in his home.His wife and son sat outside his room in Memorial Hermann Hospital in the Texas Medical Center, on the brink of making what needed to be a quick decision that could help Chapa's recovery, as well as countless other future patients.

Physicians had just told them about an experimental study that could give Chapa access to a treatment that potentially could better dissolve the blood clot in his brain and lessen his chance of a long-term disability. They would need their permission to try it on him.Another element: The study is a randomized, double-blinded and placebo-controlled trial, meaning they wouldn't know if Chapa received the experimental portion of the treatment until the trial is real time Location system.

The family weighed its options, asked to see the device and prayed. “I told them, OK, let's do it,” said his son, Michael Chapa.With that green light, Chapa became the world's first stroke patient to participate in a pivotal Phase III clinical trial for the treatment of ischemic strokes, or strokes in which blood clots occur.The therapy involves using a device that delivers ultrasound energy to the brain in combination with a blood clot-busting medication that's currently the only approved treatment for stroke patients.

“If the device is better than no device, then presumably if there's an effect and it helps more patients achieve full recovery from their stroke, then the (Food and Drug Administration) may approve the device for stroke treatment,” said Dr. Andrew Barreto, assistant professor of neurology in the stroke division at the University of Texas Health Science Center at Houston, one of 60 sites worldwide recruiting patients for the trial. “Then we would have our second-approved stroke treatment.”

The device, called the Clotbust-ER, is a hands-free head frame, worn like a helmet, that delivers ultrasound waves through the skull and to the brain using 16 probes, focusing on areas where blood clots are most likely to occur.Barreto, who's also the North American principal investigator on the study, said the waves can open up the blood clot and allow more of the drug to get into the clot, restoring blood flow quicker and potentially reduce damage.

Earlier research using ultrasound technology was done with a single-hand device that required extensive medical training. The latest design can be administered easily in any emergency room.The clinical trial will require a total of 830 patients and take about 21/2 years. Previous research using the device was sponsored by the National Institutes of Health.The current trial is sponsored by Cerevast Therapeutics, which used some technology licensed from UTHSC to design and develop the device.

Currently, the medication, tissue plasminogen activator or tPA, is the only approved treatment for ischemic stroke.While the drug works well, it doesn't have as much benefit to those with large blood clots and can cause some brain bleeding, Barreto said.“So we're adding additional treatments to tPA in the hope that we can amplify the effect,” he said.

In 2004, former UTHSC Professor Dr. Andrei Alexandrov published the results of a small safety study he led for the treatment in the New England Journal of Medicine.The study used two groups of 63 patients each: One group received the ultrasound treatment with tPA and the other received just the drug.Those given ultrasound technology with the clot-busting medication didn't suffer any increased risk of bleeding, the research showed. It also found the rate of reopening arteries in the brain blocked by a clot tripled in patients administered ultrasound energy and those patients were also less disabled at 90 days.

“We knew that they can respond to tPA and ultrasound, but there were not studies telling us what to expect at three months,” said Alexandrov, director of the comprehensive stroke center at the University of Alabama Hospital and global principal investigator for the current trial. “That's why we powered the study at 126 patients, relatively large for a safety study, but quite small for the definitive trial.”

There is no evidence that the poor eat more takeaways than any other group in our society. There may be more takeaway outlets in poor areas, but all cohorts of Kiwi society eat them regularly, both rich and poor. The one advantage for the rich is that they can afford to spend a bit more on "healthier" versions of takeaways.

What is driving our obsession with takeaways? One factor is no doubt the recession, during which people have been looking for a cheap, convenient treat.The business model of the convenience and takeaway food industry ensures that the resulting meal will be stacked full of sugar, fat and salt. This cocktail is lethal for one in four Kiwis who are a high risk for getting diabetes - a grisly condition that wipes eight years off your life.

For most Kiwis the excuse that we can't afford to eat healthily are pretty hollow, the truth is we are too lazy - or to be more politically correct, we're too time-short.That raises the question of whether government health policy hasn't priced our time correctly. Or to translate that into English - whether our "free" public health system should make it more expensive for us not to avoid crap food and save the taxpayer some dosh in paying for the consequences - let alone extend our own years of health living.

A health sector that was cheaper to access for those who have taken preventive measures to avoid the consequences of the worst of our fake food - diabetes, cancer, strokes, obesity, sleep apnoea - would be a win-win.A tax on "rubbish" food would provide the funds for the health sector to treat those too slack too avoid it. With such an abuser pays regime in place why would we care about those who eat the seeds of their own demise?

And what of that first group we discussed - the poor who can't afford to do anything else but turn up each night at the local chippie?