NCT07182955

Brief Summary

The main goal is to understand what causes reduced fitness in ANOCA and whether targeted exercise can help improve it. This study aims to better understand why patients with Angina and No Obstructive Coronary Artery Disease (ANOCA) have poor cardiorespiratory fitness and its effect on quality of life. Investigators also want to see if a structured high-intensity exercise program (HIIT), done with remote monitoring, can safely improve heart function, fitness, and quality of life in these patients. The Investigators will use a special exercise test called cardiopulmonary exercise testing to look for patterns that can help explain exercise limitations and quality of life in ANOCA before and after a remote high-intensity exercise program.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

July 11, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

ANOCA/MINOCAHigh Intensity Interval TrainingCPET PhenotypeCardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

  • Examine cardiorespiratory fitness (change in VO2max in mL/kg/min) with cardiopulmonary exercise testing (CPET) Phenotype.

    The investigators will assess VO2max (mL/kg/min) in 25 patients with ANOCA at the exercise laboratory.

    4 weeks

Secondary Outcomes (2)

  • Assess Changes in cardio-respiratory fitness (CRF) (VO2max) with High-Intensity Interval Exercise Training (HIIT) in Patients with ANOCA.

    4 weeks

  • Health Related Quality Of Life (HRQOL) questionnaire

    4 Weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week.

Exercise

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85
  • ANOCA (Anginal symptoms of chest pain or exertional dyspnea suspected to be from myocardial ischemia Invasive or CT coronary angiogram without obstructive epicardial CAD (≥50% left main or ≥70% other epicardial stenosis or fractional flow reserve ≤0.80)
  • Able to use the wearable and participate in a remote exercise program
  • Able to participate in intermittent high-intensity training.
  • Able to perform cardiopulmonary exercise testing (CPET)
  • Able to provide Health-related quality of life questionnaire (HRQOL)
  • Participants must be able to understand and provide informed consent in English and complete the study questionnaire in English

You may not qualify if:

  • Systolic heart failure (LVEF \<50% or NYHA class III symptoms)
  • Prior myocardial infarction, coronary revascularization
  • Inability to safely undergo cardiopulmonary exercise testing, based on investigator's judgment
  • Pregnancy (due to unknown effects on CPET exercise markers)
  • Inability to provide informed consent
  • Life expectancy \<1 year
  • Prisoners
  • Cognitively impaired
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (2)

  • Angadi SS, Jarrett CL, Sherif M, Gaesser GA, Mookadam F. The effect of exercise training on biventricular myocardial strain in heart failure with preserved ejection fraction. ESC Heart Fail. 2017 Aug;4(3):356-359. doi: 10.1002/ehf2.12149. Epub 2017 Mar 16.

    PMID: 28772048BACKGROUND
  • Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.

    PMID: 15007010BACKGROUND

MeSH Terms

Conditions

MINOCADyspnea

Interventions

ExerciseDosage Forms

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Jamieson M Bourque, MD, MHS

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine & Radiology, Medical Director of Nuclear Cardiology and Stress Laboratory, Medical Director of Echocardiography

Study Record Dates

First Submitted

July 11, 2025

First Posted

September 19, 2025

Study Start

August 11, 2025

Primary Completion

March 30, 2026

Study Completion

April 14, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations