TerminatedNot Applicable

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

Stopped: Recruitment not possible in study location given study population.

United States1 participantsStarted 2022-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in daily steps compared with baseline

Timeframe: 3 Months

Trial details

NCT IDNCT05440084

SponsorMinneapolis Heart Institute Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Chronic Total Occlusion trials