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HYPER-trial Hyperemic mYocardial Perfusion by adEnosine at diffeRent doses

Phase 1
Conditions
Chronic coronary syndrome
MedDRA version: 20.0Level: LLTClassification code: 10008937Term: Chronic ischemic heart disease unspecified Class: 10007541
MedDRA version: 20.0Level: LLTClassification code: 10055218Term: Ischemic heart disease Class: 10007541
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Registration Number
CTIS2023-505248-20-00
Lead Sponsor
Region Skane
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
180
Inclusion Criteria

To be included in the trial, the patients must meet all of the following criteria: 1)The subject has given their written consent to participate in the trial. 2)Are referred to Department of Clinical Physiology, Lund University, 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 To be included in the trial, the healthy subjects must meet all of the following criteria: 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 must not be included in this trial if any of the following criteria are met: 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 <30mL/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 subjects must not be included in this trial if any of the exclusion criteria for patients are met or any of the following criteria are met: 1)Blood pressure > 140/90 measured according to clinical routine 2)Known systemic disease 3)Known cardiac disease 4)Cardiovascular medication 5)Medication that might influence cardiovascular health 6)Smoking

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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