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

NCT06529848 | Recruiting DMC

• 1 other identifier: ExINOCA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Microvascular Disease; CMD

Outcome Measures

Primary Outcomes (1)

• Change in Myocardial Blood Flow Reserve (MBFR)

  Change in MBFR assessed by \[15O\]H2O-PET-scan

  From baseline and after 3 months

Secondary Outcomes (4)

• Change in symptom burden assessed by Seattle Angina Questionnaire

  From baseline and after 3 months

• Change in exercise capacity

  From baseline and after 3 months

• Change in global rest perfusion in patients with angina symptoms and CMD

  From baseline and after 3 months

• Change in global stress perfusion in patients with angina symptoms and CMD

  From baseline and after 3 months

Other Outcomes (7)

• Vascular Function Adaptations

  From baseline and after 3 months

• Changes in skin microvascular function

  From baseline and after 3 months

• Change in plasma levels of markers related to vascular function

  From baseline and after 3 months

Study Arms (2)

Exercise

ACTIVE COMPARATOR

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

Other: Exercise training

Control

NO INTERVENTION

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.

Interventions

Exercise training 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.

Also known as: Physical activity, Endurance training

Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (2)

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

Copenhagen, 2400, Denmark

NOT YET RECRUITING

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

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Interventions

Exercise; Endurance Training

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Eva Prescott, MD, DMSc

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Ylva Hellsten

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Prescott, MD, DMSc

CONTACT

004522572614; Eva.Irene.Bossano.Prescott@regionh.dk

Mads Fischer, MSc

CONTACT

+45 23 46 36 66; mf@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Clinical Professor

Model Details: Randomized controlled trial in which 100 angina patients with reduced flow reserve (INOCA patients) are randomized 1:1 to either exercise training or control (no exer-cise training).

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 31, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)