ADENOSINE for Chronic coronary syndrome|Ischemic heart disease

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial.\n- Are referred to Department of Clinical Physiology, Lund University, for suspected or known CCS or heart failure\n- 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)\n- Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)\n- No caffein intake <24h prior to the examination\n- The subject has given their written consent to participate in the trial. (healthy subjects)\n- 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) (healthy subjects)\n- No caffein intake <24h prior to the examination (healthy subjects)"}

Exclusion criteria

• {"criterion_text":"- Acute referral (in-house patients)\n- Clinically unstable\n- Acute chest pain\n- Severe or decompensated heart failure\n- Non sinus rhythm (e.g. atrial fibrillation)\n- Asthma or severe chronic obstructive pulmonary disease\n- Known chronic renal failure (eGFR <30mL/min/1.73m2)\n- AV-block II or III\n- Left Bundle Branch Block\n- Systolic blood pressure <90 mmHg or >230 mmHg at rest\n- Increased intracranial pressure\n- Known allergy or adverse reaction to adenosine or mannitol\n- Known allergy or adverse reaction to gadolinium contrast agents\n- Treatment with medication containing dipyradimol or teofyllamin/teofyllin\n- Claustrophobia\n- Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)\n- Pregnancy or breast feeding (screened by question only)\n- Inability to give informed consent due to mental state, language difficulties etc\n- Blood pressure > 140/90 measured according to clinical routine (healthy subjects)\n- Known systemic disease (healthy subjects)\n- Known cardiac disease (healthy subjects)\n- Cardiovascular medication (healthy subjects)\n- Medication that might influence cardiovascular health (healthy subjects)\n- Smoking (healthy subjects)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint, myocardial hyperemia, is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).","definition_or_measurement_approach":"Assessed by quantitative myocardial perfusion CMR imaging (ml/min/g)."}

Sweden

Earliest CTIS Part Ii Submission Date

15-02-2024

Latest Decision Or Authorization Date

05-03-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden