Status:
NOT_YET_RECRUITING
Mechanisms Behind Microvascular Dysfunction in INOCA
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
University of Copenhagen
Conditions:
Coronary Microvascular Dysfunction
Ischaemia With Non Obstructed Coronary Arteries
Eligibility:
All Genders
50+ years
Brief Summary
The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.
Detailed Description
A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as...
Eligibility Criteria
Inclusion
- Only for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) \< 2.5 or hyperemic myocardial blood flow (hMBF) \< 2.3ml/g/min
Exclusion
- Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
- Heart failure, defined as left ventricular ejection fraction of less than 40%
- Uncontrolled hypertension defined as blood pressure above target 140/90 for all
- Co-morbidity resulting in \<1 year expected survival
- Considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Unable or unwilling to exercise, e.g. due to arthritis or injury\*
- Already are regularly physically active and/or have a maximal oxygen uptake \>45 ml/kg/min
- The subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin C).
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 15 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06529861
Start Date
October 1 2024
End Date
May 15 2028
Last Update
July 31 2024
Active Locations (1)
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1
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000
Copenhagen, Denmark, 2400