Ongoing, recruitingTherapeutic use (Phase IV)Interventional

PROgnostic value of precision medicine in patients with Myocardial Infarction and non-obStructive coronary artEries: the PROMISE study

The PROMISE study is investigating how best to help people who have had a heart attack, but whose arteries are not blocked (a condition called MINOCA). Researchers are particularly interested in understanding if certain medications like warfarin, aspirin, or atorvastatin, and others, can help improve their chest pain (angina) and overall quality of life a year after their heart attack. The study also aims to understand the costs involved in treating MINOCA and explore new ways to accurately diagnose its causes and predict who might be at higher risk for future heart problems. This research will help doctors provide more precise and effective treatments for MINOCA patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrolment target

145

Start

26 Nov 2024

Myocardial infarction with non-obstructive coronary arteries (MINOCA)

What is this study about?

The PROMISE study is focused on a specific type of heart attack called MINOCA. This stands for Myocardial Infarction with Non-Obstructive Coronary Arteries. It means someone has had a heart attack, but when doctors look at their coronary arteries (the blood vessels that supply the heart), they don't find any major blockages. This can be confusing for both patients and doctors, as the usual treatments for heart attacks often focus on clearing blocked arteries.

This study aims to understand what happens to people with MINOCA over time, especially how they feel a year after their heart attack. The main things the researchers want to know are about their chest pain (angina) and their general quality of life. They will also look at how often people with MINOCA have other serious heart-related problems, like another heart attack or needing to go back to the hospital, and what the overall costs of their healthcare are.

Researchers are also interested in finding better ways to diagnose the exact cause of MINOCA and predict who might be at higher risk in the future. They are looking at special markers in the blood and using advanced scans of the heart to achieve this. By gathering all this information, the PROMISE study hopes to help doctors make more informed decisions and provide better, more tailored care for people living with MINOCA.

Key takeaways

This study focuses on heart attacks where arteries aren't blocked (MINOCA).
It aims to improve understanding of MINOCA, not test new drugs.
Participation involves sharing information about your health and treatment over a year.
The goal is to find better ways to diagnose and treat MINOCA in the future.
You'll continue to receive your standard medical care throughout the study.

Who may be eligible?

To be considered for the PROMISE study, you would need to be an adult, at least 18 years old, who has recently experienced a heart attack. The important detail is that when doctors checked your heart's arteries, they found no significant blockages. This specific condition is what the study is focused on.

Both men and women are welcome to participate in this research. The study aims to gather information from a wide range of people to understand MINOCA better.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a heart attack?
Did doctors confirm that your heart's arteries were not significantly blocked?
Are you able to attend follow-up appointments or provide health updates for about a year?

Answer every question to see your result.

What does participation involve?

If you join the PROMISE study, you'll be followed for about a year. You'll likely have your angina (chest pain) and general well-being assessed at different times, including a check-up around one year after your heart attack. This assessment will probably involve filling out questionnaires, like one called the Seattle Angina Questionnaire. You will also continue with your usual medical care, which may include taking various commonly prescribed heart medications such as aspirin, warfarin, or others your doctor deems necessary. The study will also track any future hospital visits or procedures you might have, as well as the costs associated with your healthcare. There aren't any specific new treatments directly given as part of this study; instead, it observes the effects of standard treatments and how patients are doing.

Potential risks and benefits

Taking part in the PROMISE study doesn't involve new or experimental treatments, so there are no direct extra medical risks beyond your usual care. The main benefit may be contributing to a better understanding of MINOCA, which could lead to improved diagnosis and treatment for others in the future. You might also find it reassuring to have your health closely monitored. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is MINOCA?

MINOCA stands for Myocardial Infarction with Non-Obstructive Coronary Arteries. This simply means you've had a heart attack, but when doctors looked at your heart's blood vessels, they didn't find any major blockages.

Will I receive new medicine in this study?

No, this study doesn't give you new or experimental medicines. It observes how well existing, commonly used heart medicines and treatments work for people with MINOCA.

What will happen during the study?

You'll be asked about your chest pain and general health, especially at one year after your heart attack. The study will also keep track of your regular medical care and any hospital visits.

How long will I be in the study?

You'll be followed for about one year after your heart attack.

Why is this study important?

It's important because it helps doctors understand MINOCA better, find new ways to diagnose it, and ultimately improve care for people who have this type of heart attack.