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Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start standard dose adenosine followed by high dose adenosine | Active Comparator | Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 140 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 210 μg/kg/min adenosine. |
|
| Start high dose adenosine followed by standard dose adenosine | Active Comparator | Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 210 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 140 μg/kg/min adenosine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine | Drug | Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial hyperemia | The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g). | During adenosine infusion, 4-6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate response | Compare heart rate (beat/min) at standard and high dose adenosine | During adenosine infusion, 4-6 minutes |
| Blood pressure response | Compare systolic blood pressure (mmHg) at standard and high dose adenosine |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | The association between sex (female and male) and adenosine response | In questionnaire obtained approximately 30 minutes before CMR examination |
| Age | The association between age (years) and adenosine response |
Inclusion Criteria:
Patients:
Healthy volunteers:
Exclusion Criteria:
Patients:
Healthy volunteers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Engblom, MD, PhD | Contact | 046171000 | henrik.engblom@med.lu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital | Recruiting | Lund | Sweden |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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The subjects will be randomized to start with one of the two adenosine doses, followed by the other dose 10 minutes later during the same examination.
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The subject will be blinded to the order of adenosine doses.
| During adenosine infusion, 4-6 minutes |
| Symptoms | Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine | During adenosine infusion, 4-6 minutes |
| In questionnaire obtained approximately 30 minutes before CMR examination |
| Ejection fraction | The association between ejection fraction (%) assessed from CMR images and adenosine response | Measured in the obtained short-axis cine images within approximately 6 months after acquisition |
| Serum-caffeine | The association between serum caffeine levels (mg/L) assessed from blood samples and adenosine response | Blood samples are analysed within 9 months |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |