Mechanisms Behind Microvascular Dysfunction in INOCA

NCT ID: NCT06529861

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-05-15

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 ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, an area yet to be explored.

This study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.

Conditions

Coronary Microvascular Dysfunction; Ischaemia With Non Obstructed Coronary Arteries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Ischemia and no obstructive coronary arteries

patients with angina and reduced myocardial blood flow reserve

[15O]H2O-PET Imaging

Intervention Type: DIAGNOSTIC_TEST

This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer \[15O\]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.

Control

controls without angina

[15O]H2O-PET Imaging

Intervention Type: DIAGNOSTIC_TEST

This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer \[15O\]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.

Interventions

[15O]H2O-PET Imaging

This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer \[15O\]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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 Criteria

• 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva Prescott

MD Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ylva Hellsten, Professor

Role: STUDY_CHAIR

Department of Nutrition, Exercise and sports, University of Copenhagen

Locations

Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Eva Prescott, MD, DMSc

Role: CONTACT

Eva.Irene.Bossano.Prescott@regionh.dk

22572614

Mads Fischer, Ph.D.

Role: CONTACT

mf@nexs.ku.dk

24485450

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ExINOCA - Part I

Identifier Type: -

Identifier Source: org_study_id