Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Overview
- Phase
- Phase 4
- Intervention
- Adenosine
- Conditions
- Chronic Coronary Syndrome
- Sponsor
- Region Skane
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Myocardial hyperemia
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •No caffein intake \<24h prior to the examination
- •Healthy volunteers:
- •The subject has given their written consent to participate in the trial.
- •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)
- •No caffein intake \<24h prior to the examination
Exclusion Criteria
- •Acute referral (in-house patients)
- •Clinically unstable
- •Acute chest pain
- •Severe or decompensated heart failure
- •Non sinus rhythm (e.g. atrial fibrillation)
- •Asthma or severe chronic obstructive pulmonary disease
- •Known chronic renal failure (eGFR \<45mL/min/1.73m2)
- •AV-block II or III
- •Left Bundle Branch Block
- •Systolic blood pressure \<90 mmHg or \>230 mmHg at rest
Arms & Interventions
Start standard dose adenosine followed by high dose adenosine
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.
Intervention: Adenosine
Start high dose adenosine followed by standard dose adenosine
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.
Intervention: Adenosine
Outcomes
Primary Outcomes
Myocardial hyperemia
Time Frame: During adenosine infusion, 4-6 minutes
The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).
Secondary Outcomes
- Heart rate response(During adenosine infusion, 4-6 minutes)
- Blood pressure response(During adenosine infusion, 4-6 minutes)
- Symptoms(During adenosine infusion, 4-6 minutes)