Chronic Coronary Syndrome, Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Myocardial perfusion, Cardiac Magnetic Resonance, Adenosine
Brief summary
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.
Interventions
DRUGAdenosine
Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
The subject will be blinded to the order of adenosine doses.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients: 1. The subject has given their written consent to participate in the trial. 2. Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure 3. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old) 4. Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c) 5. No caffein intake \<24h prior to the examination Healthy volunteers: 1. The subject has given their written consent to participate in the trial. 2. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old) 3. No caffein intake \<24h prior to the examination
Exclusion criteria
Patients: 1. Acute referral (in-house patients) 2. Clinically unstable 3. Acute chest pain 4. Severe or decompensated heart failure 5. Non sinus rhythm (e.g. atrial fibrillation) 6. Asthma or severe chronic obstructive pulmonary disease 7. Known chronic renal failure (eGFR \<45mL/min/1.73m2) 8. AV-block II or III 9. Left Bundle Branch Block 10. Systolic blood pressure \<90 mmHg or \>230 mmHg at rest 11. Increased intracranial pressure 12. Known allergy or adverse reaction to adenosine or mannitol 13. Known allergy or adverse reaction to gadolinium contrast agents 14. Treatment with medication containing dipyradimol or teofyllamin/teofyllin 15. Claustrophobia 16. Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc) 17. Pregnancy or breast feeding (screened by question only) 18. Inability to give informed consent due to mental state, language difficulties etc Healthy volunteers: 1. Any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial hyperemia | During adenosine infusion, 4-6 minutes | The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate response | During adenosine infusion, 4-6 minutes | Compare heart rate (beat/min) at standard and high dose adenosine |
| Blood pressure response | During adenosine infusion, 4-6 minutes | Compare systolic blood pressure (mmHg) at standard and high dose adenosine |
| Symptoms | During adenosine infusion, 4-6 minutes | Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine |
Countries
Sweden
Contacts
CONTACTHenrik Engblom, MD, PhD
Outcome results
None listed