Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study

NCT ID: NCT06529848

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-05-15

Brief Summary

The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function.

Hypotheses:

The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body.

The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.

Detailed Description

A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD 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, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored.

This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition.

The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.

Conditions

Coronary Microvascular Disease; CMD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

The exercise intervention consists of supervised training 40-50 minutes x 3 weekly for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: OTHER

The training sessions are consist of cycling and as follows: a 10 min warm-up at a light intensity, 20-35 min of cycling exercise in intervals at varying intensities from light (~60% of max heart rate) to more intensive (80-90% of max heart rate) and ending with 5 min of warm-down at a light intensity. The training intensity will be progressive during the course of the intervention period. The cycling training sessions are supervised .

Home training is allowed up to once a week if participants are able to adhere to the prescribed intensity levels.

Training sessions are closely monitored to ensure effectiveness and safety. This includes heart rate monitoring, perceived exertion assessment.

Control

The participants who are randomized to the no-training group will be offered exercise train-ing after the intervention is completed. Participants will be encouraged to not change their lifestyle or medication throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

The training sessions are consist of cycling and as follows: a 10 min warm-up at a light intensity, 20-35 min of cycling exercise in intervals at varying intensities from light (~60% of max heart rate) to more intensive (80-90% of max heart rate) and ending with 5 min of warm-down at a light intensity. The training intensity will be progressive during the course of the intervention period. The cycling training sessions are supervised .

Home training is allowed up to once a week if participants are able to adhere to the prescribed intensity levels.

Training sessions are closely monitored to ensure effectiveness and safety. This includes heart rate monitoring, perceived exertion assessment.

Intervention Type: OTHER

Other Intervention Names

Physical activity; Endurance training

Eligibility Criteria

Inclusion Criteria

• Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) < 2.5 or hyperemic myocar-dial blood flow (hMBF)<2.3 ml/g/min using [15O]H2O-PET
• No obstructive coronary artery disease

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 un-suitable candidate for the study.
• Unable or unwilling to exercise, e.g. due to arthritis or in-jury*
• Already are regularly physically active and/or have a maxi-mal oxygen uptake >45 ml/kg/min

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

Eva Prescott, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Exercise and sports, University of Copenhagen

Ylva Hellsten

Role: PRINCIPAL_INVESTIGATOR

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

Site Status: NOT_YET_RECRUITING

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

Frederiksberg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Eva Prescott, MD, DMSc

Role: CONTACT

Eva.Irene.Bossano.Prescott@regionh.dk

004522572614

Mads Fischer, MSc

Role: CONTACT

mf@nexs.ku.dk

+45 23 46 36 66

Facility Contacts

Eva Prescott, MD, DMSc

Role: primary

Eva.Irene.Bossano.Prescott@regionh.dk

+45 4026 2134

Mads Fischer, MSc

Role: backup

mf@nexs.ku.dk

+4524485450

Eva Prescott, MD, DMSc

Role: primary

Eva.Irene.Bossano.Prescott@regionh.dk

+45 4026 2134

Mads Fischer, MSc

Role: backup

mf@nexs.ku.dk

+4524485450

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ExINOCA

Identifier Type: -

Identifier Source: org_study_id