Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome
Sweden505 participantsStarted 2015-09-02
Plain-language summary
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).
The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with stable angina pectoris or suspected angina pectoris who are scheduled for coronary angiography
* Age 18 years - 85 years
* Life expectancy \>2 years
Exclusion Criteria:
* Acute coronary syndrome (ST-elevation myocardial infarction \[STEMI\], non-ST-elevation myocardial infarction \[NSTEMI\] and unstable angina pectoris)
* Known CHF
* Prior heart transplantation
* Prior coronary artery by-pass grafting
* Hypertrophic cardiomyopathy (Septum \>15 mm)
* Valvular disease
* Not eligible for coronary angiogram
* Cancer within three years of admission
* Peri-myocarditis
* Atrial fibrillation with heart beats per minute \>120
* Asthma
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of all-cause mortality, MI and/or hospitalization due to CHF
Timeframe: Study completion, approximately 5 years