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Clinical Trials/CTIS2023-505248-20-00
CTIS2023-505248-20-00
Active, not recruiting
Phase 1

HYPER-trial Hyperemic mYocardial Perfusion by adEnosine at diffeRent doses

Region Skane0 sites180 target enrollmentNovember 29, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic coronary syndrome
Sponsor
Region Skane
Enrollment
180
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 29, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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