Personalised knowledge to reduce the risk of stroke (PERKS-International): protocol for a randomised controlled trial

 Rather than actually doing the difficult work of solving stroke you went down the lazy route of prevention. Anyone coming to me with such research wouldn't stay employed in stroke very long.  My risk of stroke was incredibly small yet I had one because my Dad's doctor didn't tell him to have his kids tested for carotid artery problems when he was diagnosed with 80% blockage.  Yes, mine was totally preventable but none of the stroke risk calculators look for that risk.

Personalised knowledge to reduce the risk of stroke (PERKS-International): protocol for a randomised controlled trial

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Seana Gall, Valery L. Feigin, MD, PhD, Amanda G Thrift, ...

First Published June 30, 2022 Research Article 

https://doi.org/10.1177/17474930221113430

Article information

Abstract

Abstract

Rationale

Theoretically, most strokes could be prevented through the management of modifiable risk factors. The Stroke Riskometer™ mobile phone application (hereon ‘The App’) uses an individual’s data to provide personalised information and advice to reduce their risk of stroke.

Aims

To determine the effect of The App on a combined cardiovascular risk score (Life’s Simple 7®, LS7) of modifiable risk factors at 6 months post-randomisation.

Methods and design

PERKS-International is a Phase III, multicentre, prospective, pragmatic, open-label, single-blinded endpoint, 2-arm randomised controlled trial (RCT). Inclusion criteria are: age ≥35 and ≤75 years; ≥2 LS7 risk factors; smartphone ownership; no history of stroke/myocardial infarction/cognitive impairment/terminal illness. The intervention group (IG) will be provided with The App and the usual care group (UCG) is provided with generic online information about risk factors, but not be informed about The App. Face-to-face assessments will be conducted at baseline and 6 months, and online at 3 and 12 months. The RCT includes a process and economic evaluation.

Study outcomes and sample size

The primary outcome is a difference in the mean change in LS7 (7 individual items: blood pressure, cholesterol, glucose, body mass index [BMI], smoking, physical activity and diet) from baseline to 6 months post-randomisation with intention-to-treat analysis. Secondary outcomes include: change in individual LS7 items, quality of life; stroke awareness, adverse events; health service use; and costs. Based on pilot data, 790 participants (395 IG, 395 UCG) will be required to provide 80% power (two sided α=0.05) to detect a mean difference in the LS7 of ≥0.40 (SD 1.61) in IG compared to 0.01 (SD 1.44) in the UCG at 6 months post-randomisation.

Discussion

Stroke is largely preventable. This study will provide evidence of the effectiveness of a mobile app to reduce stroke risk.

Trial registration

ACTRN12621000211864

Keywords

Stroke, Prevention, Protocols, Epidemiology, Risk factors, Intervention

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Protein-based risk score for cardiovascular outcomes in stable coronary heart disease

There are many risk calculators out there. Which one is in your doctors protocol?
Protein-based risk score for cardiovascular outcomes in stable coronary heart disease

JAMA, 07/12/2016 Ganz P, et al.

Researchers used large–scale analysis of circulating proteins with a goal to derive and validate a score to predict risk of cardiovascular outcomes among patients with CHD. They concluded that only modest discriminative accuracy was provided among patients with stable CHD although a risk score based on 9 proteins performed better than the refit Framingham secondary event risk score in predicting cardiovascular events. To assess whether the score is more accurate in a lower–risk population, further research is needed.

Methods

• Design of the study is prospective cohort, in participants with stable CHD.
• Outpatients from San Francisco were enrolled from 2000 through 2002 and followed up through November 2011 (<=11.1 years), for the derivation cohort (Heart and Soul study) and from 2006 through 2008 and followed up through April 2012 (5.6 years), for the validation cohort (HUNT3, a Norwegian population–based study).
• 1130 proteins were measured in plasma samples, using modified aptamers
• Derivation and validation of 9–protein risk score was done for 4–year probability of myocardial infarction, stroke, heart failure, and all–cause death.
• Researchers used tests, including the C statistic, to assess performance of the 9–protein risk score, which was compared with the Framingham secondary event model, refit to the cohorts in this study.
• From paired samples which were collected 4.8 years apart, evaluation of within–person change in the 9–protein risk score was done in the Heart and Soul study.

Results

• The results demonstrated that of the 938 samples analyzed from the derivation cohort, median age of the participants enrolled was 67.0 years and 82% were men, whereas of the 971 samples analyzed from the validation cohort, participants’ median age at enrollment was 70.2 years, and 72% were men.
• C statistics in the derivation cohort were: 0.66 for refit Framingham, 0.74 for 9–protein, and 0.75 for refit Framingham plus 9–protein models, and in the validation cohort were: 0.64 for refit Framingham, 0.70 for 9–protein, and 0.71 for refit Framingham plus 9–protein models.
• C statistics were increased by 0.09 (95% CI, 0.06–0.12) in the derivation cohort and by 0.05 (95% CI, 0.02–0.09) in the validation cohort, by adding the 9–protein risk score to the refit Framingham model .
• The integrated discrimination index for the 9–protein model was 0.12 (95% CI, 0.08–0.16) in the derivation cohort and 0.08 (95% CI, 0.05–0.10) in the validation cohort, compared with the refit Framingham model.
• Researchers analysed that in paired samples among 139 participants with cardiovascular events after the second sample, absolute within–person annualized risk increased more for the 9–protein model (median, 1.86% [95% CI, 1.15%–2.54%]) than for the refit Framingham model (median, 1.00% [95% CI, 0.87%–1.19%]) (P=.002), while among 375 participants without cardiovascular events, both scores changed less and similarly (P=.30).

Cardiovascular risk tool overestimates actual chance of cardiovascular events

A completely worthless article, no link to the problem calculator in question.
http://medicalxpress.com/news/2016-05-cardiovascular-tool-overestimates-actual-chance.html
A widely recommended risk calculator for predicting a person's chance of experiencing a cardiovascular disease event—such as heart attack, ischemic stroke or dying from coronary artery disease—has been found to substantially overestimate the actual five-year risk in adults overall and across all sociodemographic subgroups. The study by Kaiser Permanente was published today in the Journal of the American College of Cardiology.

Atherosclerotic cardiovascular disease, also known as atherosclerosis, is a silent disease that starts early in life and can have serious consequences, including heart attack, stroke or even death if untreated. It progresses through a build-up of cholesterol plaque and other substances in the walls of arteries, causing obstruction of blood flow. Evidence-based use of statins to reduce cholesterol has been a cornerstone for primary prevention of atherosclerotic cardiovascular disease events in those patients who are at high enough risk to benefit.
Publication of the American College of Cardiology and American Heart Association Pooled Cohort risk equation for estimating the likelihood of atherosclerotic cardiovascular disease events in 2013 was considered an important step forward. However, the equation was developed from several groups of enrolled volunteers primarily conducted in the 1990s with limited ethnic diversity and age range, so its accuracy may vary in current community-based populations.
"Our study provides critical evidence to support recalibration of the risk equation in 'real world' populations, especially given the individual and public health implications of the widespread application of this risk calculator," said senior author Alan S. Go, MD, chief of Cardiovascular and Metabolic Conditions Research at the Kaiser Permanente Northern California Division of Research.
The actual incidence of atherosclerotic cardiovascular disease events over five years was substantially lower than the predicted risk in each category of the ACC/AHA Pooled Cohort equation:

• For predicted risk less than 2.5 percent, actual incidence was 0.2 percent
• For predicted risk between 2.5 and 3.74 percent, actual incidence was 0.65 percent
• For predicted risk between 3.75 and 4.99 percent, actual incidence was 0.9 percent
• For predicted risk equal to or greater than 5 percent, actual incidence was 1.85 percent

"From a relative standpoint, the overestimation is approximately five- to six-fold," explained Dr. Go. "Translating this, it would mean that we would be over-treating a good many people based on the risk calculator."

The study followed a population of 307,591 men and women aged 40 to 75 years old, including non-Hispanic whites, non-Hispanic blacks, Asian, Pacific Islanders and Hispanics, from 2008 through 2013 and had complete five-year follow-up. The study population did not include patients with diabetes, prior atherosclerotic cardiovascular disease, or prior use of lipid-lowering therapy such as statins.
To determine whether the risk equation might be improved by being recalibrated in "real world" clinical care, Kaiser Permanente researchers examined a large, multi-ethnic, community-based population of the health plan's members in Northern California whose cholesterol levels and other clinical measures could theoretically trigger a discussion about whether to consider starting cholesterol-lowering therapy based on estimated risk using the ACC/AHA Pooled Cohort tool.
Among both men and women, there was consistent overestimation of observed five-year atherosclerotic cardiovascular disease incidence in each predicted risk category, with similarly poor calibration in both genders. Researchers also found consistent overestimation of actual atherosclerotic cardiovascular disease risk in each of the major ethnic subgroups. Results were also similar across measures of socioeconomic status.
On the other hand, researchers found that observed atherosclerotic cardiovascular disease risk was substantially closer to that predicted by the ACC/AHA tool among adults with diabetes who were not treated with statin therapy for primary prevention.
"Statin therapy is a mainstay treatment for millions of Americans," said lead author Jamal S. Rana, MD, PhD, cardiologist at Kaiser Permanente Oakland Medical Center and adjunct investigator with the Division of Research. "Our study highlights the importance of ongoing research and dialogue in this area to provide more rigorous evidence to guide treatment for the patients most likely to benefit from this approach."

Explore further: Analysis supports use of risk equations to guide statin therapy

Journal reference: Journal of the American College of Cardiology

Panel backs aspirin for heart health in certain adults

None of the stroke risk calculators I've taken have ever shown me to be higher than a low risk. So that great stroke association would determine why all these calculators are missing predicting strokes. Well in a perfect world that would occur, but in reality we have crapola for stroke associations, doing nothing useful for survivors.
http://www.cbsnews.com/news/aspirin-heart-health-cancer-prevention/

A government task force says a daily low-dose aspirin could help certain people in their 50s and 60s prevent a first heart attack or stroke - and they might get some protection against colon cancer at the same time.
The U.S. Preventive Services Task Force issued draft guidelines Monday recommending aspirin only if people meet a strict list of criteria - including a high risk of heart disease and a low risk of bleeding side effects.
The guidelines said the recommendation is strongest for 50-somethings, but that doctors should decide aspirin therapy on a case-by-case basis for people in their 60s, who can expect a smaller benefit.
Potential candidates should have at least a 10 percent risk of a heart attack or stroke over the next decade, have a life expectancy of at least 10 years and be willing to take daily aspirin that long, and not have other health conditions that cause bleeding, the guidelines said. That's because prolonged aspirin use can trigger serious bleeding in the gastrointestinal tract or brain.
When it comes to dosing, the range that has been studied runs the gamut from high to low, but CBS News medical contributor Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City, says sticking to low-dose baby aspirin is best.
"The evidence shows that there's really no incremental benefit of going over 81 milligrams, and in fact, you may increase bleeding risk by going over," she told "CBS This Morning."
Aspirin therapy has long been recommended for heart attack survivors, but who should try it for what's called primary prevention - protection of a first heart attack or stroke - is less clear. And while studies suggest years of daily aspirin use may lower the risk of colon cancer, no major health organizations recommend taking it solely for that reason.
Neither do the task force guidelines - the aspirin decision is supposed to be made on the basis of patients' heart health - but it concluded the cancer information would be useful as doctors and patients discuss the choice.
"If you're a person trying to decide whether to take aspirin, you'd want to be aware of all the potential benefits and the potential harms," said Dr. Douglas Owens, a Stanford University professor and task force member.
And could aspirin help reduce the risk of other cancers?
"There's some research to suggest it might, but the evidence to date is really just for colon cancer and you have to take the aspirin for more than 10 years to start seeing the benefit in terms of decreasing your risk of colon cancer and decreasing your risk of dying from colon cancer," Narula said.
The task force said there's not enough evidence to assess aspirin therapy for those under 50 or over 69. The updated guidelines back aspirin for a narrower age range than the last time the task force weighed the question, but for the first time adds information about the possible cancer benefit if people use aspirin long enough.
The guidelines are in line with American Heart Association recommendations, said Dr. Elliott Antman, a Harvard University professor and former AHA president who welcomed them.
In contrast, the Food and Drug Administration last year ruled that there wasn't enough evidence to support marketing aspirin for prevention of first heart attacks.

Will You Die in 5 Years? This New Test May Tell You - UbbLE Risk Calculator

Discussion of it here:

Will You Die in 5 Years? This New Test May Tell You - UbbLE Risk Calculator

The calculator here:

UbbLE Risk Calculator

My five-year risk of dying is 3.1%

I do consider my health excellent. And if I remove the stroke from the answers it is:

Your five-year risk of dying is 2.5%

Starting Primary Prevention Earlier With Statins

You can check out the atherosclerotic cardiovascular disease (ASCVD) calculator here:

ASCVD Risk Estimator

My 10 year risk is 4.7%, lifetime is 46%.

According to this I should not need to be on statins. Never follow anything I do, I'm stroke-addled.

Starting Primary Prevention Earlier With Statins

Robinson JG.

Author information

Abstract

The 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults was based on a systematic review of randomized trials with atherosclerotic cardiovascular disease (ASCVD) outcomes and meta-analyses of these trials published through 2011. With evidence of an ASCVD risk reduction benefit greatly outweighing the potential for adverse effects, the guideline recommends statin therapy for primary prevention in those with ≥7.5% 10-year ASCVD risk and consideration of statin therapy in those with 5% to <7.5% 10-year ASCVD risk. Subsequent meta-analyses of the statin trials support these recommendations and have additionally found a reduction in total mortality in lower-risk subjects. Additional evidence from imaging trials and epidemiologic studies suggests that initiation of statin therapy earlier in the course of ASCVD could have the potential to more effectively prevent age-related progression of atherosclerosis. Given the high levels of suboptimal risk factors in adults and the safety and availability of low-cost generic statins, a consideration of all the available evidence strongly supports earlier intervention for the primary prevention of ASCVD. In conclusion, earlier initiation of statin therapy has the potential to have a large long-term impact on the heavy burden of cardiovascular disease in the aging populations.