Coronary Artery Disease Clinical Trial
Official title:
Coronary Microvascular Dysfunction in Chronic Coronary Syndrome - Invasive Assessment With Thermo-dilution Technique in the LAD and Biobanking in an All-comer Population
Verified date | March 2024 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 505 |
Est. completion date | December 28, 2022 |
Est. primary completion date | June 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS) | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Abbott |
Sweden,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of all-cause mortality, MI and/or hospitalization due to CHF | Cumulative rate of all-cause mortality, MI and/or hospitalization due to CHF at study completion | Study completion, approximately 5 years | |
Secondary | Rate of all-cause mortality | Cumulative rate of all-cause at study completion | Study completion, approximately 5 years | |
Secondary | Rate of hospitalization due to CHF. | Cumulative rate of hospitalization due to CHF at study completion | Study completion, approximately 5 years | |
Secondary | Rate of all-cause mortality and/or MI | Cumulative rate of all-cause mortality and MI at study completion | Study completion, approximately 5 years | |
Secondary | Rate of MI | Cumulative rate of MI at study completion | Study completion, approximately 5 years | |
Secondary | Rate of stroke | Cumulative rate of Stroke at study completion | Study completion, approximately 5 years | |
Secondary | Rate of ischemic stroke | Cumulative rate of Ischemic stroke at study completion | Study completion, approximately 5 years | |
Secondary | Rate of unscheduled revascularization | Cumulative rate of Unscheduled revascularization at study completion | Study completion, approximately 5 years |
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