Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity

NCT ID: NCT05440084

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-01

Brief Summary

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Heart disease is a leading cause of death in the US. . Heart blood vessel chronic total occlusions are 100% blockages of the heart vessels. These patients often suffer from chest pain, shortness of breath, and depression. Heart doctors thread special cables from the groin and wrist to the heart and open up these 100% blocked vessels. . This treatment improves symptoms and quality of life. Exercise is very beneficial for health. Previous studies suggest that even a 1000 steps/day increase in daily steps can improve health. But, patients with occluded heart vessels are often inactive because they have chest pain, feeling tired, or are short of breath. It is unknown whether opening these 100% blocked heart vessels will help patients have a more active lifestyle, which is good for health. The goal is to measure the impact of opening these occluded heart vessels on daily exercise in this project. Specifically, the investigators will give a smart watch to patients referred for this treatment. The smart watch will track the patients' daily steps before and after the procedure.

Detailed Description

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The investigators will compare the daily steps before and after the procedure to understand if the patients are more active. In addition to tracking daily steps, The investigators will track calorie expenditure with the watch.

The investigators will also use surveys to evaluate chest pain and depression. In sum, the investigators will study the impact of opening occluded heart vessels on daily exercise. If the investigators find that this routinely used treatment leads to increased daily steps, the investigators will know better which patients this treatment can help live longer and healthier

Conditions

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Chronic Total Occlusion Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients referred for CTO PCI

Chronic total occlusion percutaneous coronary intervention

Intervention Type PROCEDURE

Chronic total occlusion percutaneous coronary intervention

Interventions

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Chronic total occlusion percutaneous coronary intervention

Chronic total occlusion percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Willing and able to provide informed consent
3. Patients referred for clinically indicated CTO-PCI
4. Access to smart phone (Apple or Android platform)
5. Willing and able to wear a smart watch
6. Clinically stable and able to walk/ exercise independently

Exclusion Criteria

1. Inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion)
2. Plan for major surgical procedure (other than CTO PCI) which would limit exercise capability
3. Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanouil Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1913793

Identifier Type: -

Identifier Source: org_study_id

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