What is the personalized prevention program (PPP) studying for coronary heart disease?

The PPP is being studied to see if it can reduce the risk of serious heart problems like heart attacks, heart failure, or cardiovascular death in people with high-risk stable coronary heart disease. The study also looks at how useful certain biomarkers are for predicting these risks and evaluates the cost-effectiveness of the prevention approach.

Who may be eligible for this coronary heart disease clinical trial?

Adults aged 30 to 80 years with stable coronary heart disease who have significant artery blockage or recent heart attack may be eligible. Participants need to be able to attend all study visits and use a smartphone. People with recent hospitalizations for heart events, severe heart failure, or serious other conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this coronary heart disease clinical trial?

Study-related care, including the study program and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 30Years - 80Years

All Genders

ID04433052

Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in High Risk Stable Coronary Heart Disease Patients

Led by Tampere University · Updated on 2023-06-12

12000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized prevention program PPP for people with stable coronary heart disease CHD who are at high risk of cardiovascular events. The study includes two parts Part A screens 12,000 stable CHD subjects using biomarkers to identify those at highest risk, while Part B is a randomized clinical trial comparing usual care to the PPP in 2,000 high-risk subjects. The goal is to assess the clinical value and cost-effectiveness of the PPP and validate risk biomarkers for predicting cardiovascular events. Participants in the PPP group will visit the study site six times over three years to receive lifestyle coaching, exercise prescriptions, and medication guidance following European Society of Cardiology guidelines. These activities are supported by digital tools called the CoroPrevention Tool Suite. The usual care group will continue receiving standard care from their physicians and have two study visits during the three years. Participants will undergo evaluations including biomarker measurements, behavioral assessments, questionnaires on nutrition and exercise, and monitoring of cardiovascular events. The study will track outcomes like cardiovascular death, heart attacks, and heart failure over three years. Researchers will also study the impact of behavioral changes, adherence to exercise and medication prescriptions, and the economic value of the prevention program. Safety and progress will be monitored throughout the study period.

CONDITIONS

Brief Title

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

Who Can Participate

Age: 30Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent form
Male or female aged 30 to 80 years on the day of enrollment
More than 50% blockage in one or more major coronary arteries on angiography or CT within the past year
Or myocardial infarction (type I or II) during the past year

You will not qualify if you...

Hospitalization for acute coronary syndrome, myocardial infarction, stroke, coronary revascularization, or acute heart failure within the past 30 days
New York Heart Association class III-IV heart failure with marked activity limitation
Uncontrolled arrhythmias such as ventricular tachycardias
Undergoing dialysis due to severe renal disease
Diseases severely limiting exercise, such as rheumatoid arthritis or neurological or orthopedic diseases
Known aplastic or hemolytic anemia
Non-coronary diseases limiting life expectancy to less than three years, such as malignancy
Participation in another interventional study
Inability or unwillingness to attend all scheduled visits or use a smartphone application

Research Team

Hanna Marttila, MSc

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here