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Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry

This study is called the Mainz Intracoronary Database and focuses on heart health. It's essentially a registry that collects information from people who are having a special heart scan called a coronary angiography in Mainz, Germany. Doctors are interested in understanding conditions like coronary artery disease, where the heart's blood vessels are narrowed, and microvascular dysfunction, which affects the tiny blood vessels in the heart. The study simply watches and collects information; no new treatments are given. Some patients will be contacted by phone over several years to see how they are doing, and some anonymous information from past patients will also be added to the database.

At a glance

Status
Recruiting
Sponsor
Johannes Gutenberg University Mainz
Enrolment target
1,000
Start
01 Sep 2013
Estimated completion
01 Sep 2028

What is this study about?

This study, called the Mainz Intracoronary Database, is like a detailed observation project. It aims to collect a lot of information from people who are having a routine heart procedure called a coronary angiography at a hospital in Mainz, Germany. This procedure involves taking X-ray pictures of the heart's blood vessels to check for problems.

The main goal is to learn more about two common heart conditions: coronary artery disease (where the main heart arteries get narrowed or blocked) and microvascular dysfunction (which affects the very small blood vessels in the heart). By gathering information from many patients over time, doctors hope to get a clearer picture of how these conditions develop and affect people. It's important to understand that this is purely an 'observational' study, meaning that no new treatments or medicines are being tested. Doctors are simply recording what they see and what happens to patients as part of their regular care.

The study also includes information from some patients who have had a special device called an Aborb bioresorbable scaffold placed in their arteries. This device gradually dissolves over time. Additionally, information from past patients will be added to the database anonymously, which means their names are removed to protect their privacy. This helps build a larger picture of heart health in the region.

Key takeaways

  • This study collects information about heart health in Mainz, Germany.
  • It helps doctors understand heart artery problems and tiny blood vessel issues.
  • No new treatments or medications are given; it's purely observational.
  • Participation involves either phone calls for updates or anonymous data collection.
  • Your medical care is not affected by whether you join or not.
  • You can choose not to participate at any time.

Who may be eligible?

To be part of this study, the main thing is that you are already scheduled to have a coronary angiography (a special heart scan) due to a medical reason.

There are no specific reasons that would prevent you from taking part. This means that if your doctor thinks you need this heart scan, you could potentially be included in the study.

The study is open to adults of any age and both men and women.

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.

  1. Are you scheduled to have a coronary angiography?
  2. Will you be having this procedure in Mainz, Germany?
  3. Do you understand that there are no specific exclusion criteria?
  4. Are you an adult of any age?
  5. Are you male or female?
Answer every question to see your result.

What does participation involve?

If you are included in this study, you won't need to do anything extra beyond your usual medical care. There are no special treatments, medicines, or procedures given just for the study.

For some patients, a small amount of blood might be taken during your heart scan if doctors notice a specific issue called 'coronary slow flow'. This is done to help understand that condition better.

If you are part of the main group of patients, the study team might contact you by phone at different times after your heart scan – at 3, 6, 9, and 12 months, and then again after 2, 5, and 10 years. These calls are just to check in and see how you are doing. For some other patients, their anonymous medical information will simply be added to a database without any direct contact.

Potential risks and benefits

Because this is an observational study, where no new treatments are given, there are no additional risks beyond those associated with your regular medical care, such as the coronary angiography procedure itself. There are no direct personal benefits for participating, but by allowing your routine medical information to be collected, you will be helping doctors learn more about heart conditions, which could benefit future patients. You always have the right to decide not to take part or to withdraw your information at any time, without it affecting your medical care.

Locations (1)

  • University Medical Center Mainz - 2 Medizinische Klinik
    Verified postcode
    Mainz, Germany· Recruiting

Common questions

What is a coronary angiography?

It's a special X-ray test that uses dye to help doctors see the blood vessels in your heart to check for any blockages or narrowing.

Will I get any new medicine or treatment in this study?

No, this study is 'observational', meaning doctors are just collecting information. You won't receive any new treatments or medicines because of it.

Will my name be used in the study?

For some parts of the study, your information will be added anonymously, meaning your name won't be connected to it to protect your privacy.

How long will the study follow me?

If you're in the group that gets phone calls, you might be contacted over a period of 10 years after your initial heart scan.

Do I have to take part if my doctor asks me?

No, taking part is completely your choice. Your decision won't affect the medical care you receive.

How to find out more

Tommaso Gori, PhD, Dott medicina e Chirurgia

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Mainz Intracoronary Database. The Coronary Slow-flow and Mic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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