Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The subject has given their written consent to participate in the trial.
Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
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)
Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
Disqualifiers
Acute referral (in-house patients)
Clinically unstable
Acute chest pain
Severe or decompensated heart failure
Trial design
Design model
Crossover
Treatments tested in this trial
Adenosine
DrugStandard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Start standard dose adenosine followed by high dose adenosineActive comparator 1 intervention
Group B: Start high dose adenosine followed by standard dose adenosineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Myocardial hyperemia
The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).
Time frame
During adenosine infusion, 4-6 minutesSecondary outcomes
1
Heart rate response
Compare heart rate (beat/min) at standard and high dose adenosine
Time frame
During adenosine infusion, 4-6 minutes2
Blood pressure response
Compare systolic blood pressure (mmHg) at standard and high dose adenosine
Time frame
During adenosine infusion, 4-6 minutes3
Symptoms
Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine
Time frame
During adenosine infusion, 4-6 minutesOther outcomes
1
Sex
The association between sex (female and male) and adenosine response
Time frame
In questionnaire obtained approximately 30 minutes before CMR examination2
Age
The association between age (years) and adenosine response
Time frame
In questionnaire obtained approximately 30 minutes before CMR examination3
Ejection fraction
The association between ejection fraction (%) assessed from CMR images and adenosine response
Time frame
Measured in the obtained short-axis cine images within approximately 6 months after acquisition4
Serum-caffeine
The association between serum caffeine levels (mg/L) assessed from blood samples and adenosine response
Time frame
Blood samples are analysed within 9 monthsSponsors and contacts
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Source ClinicalTrials.gov