Chronic Total OcclusionNCT05440084
Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity
An observational study of Chronic Total Occlusion and Occlusion, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion, Occlusion
- What is being tested?
- Chronic total occlusion percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for CTO PCI at Minneapolis Heart Institute
Who may be able to join
- 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
Who cannot join
- Inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion)
- Plan for major surgical procedure (other than CTO PCI) which would limit exercise capability
- Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
About this study
Official title: Impact of Chronic Total Occlusion Percutaneous Coronary Intervention on Regular Physical Activity
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.
Read the detailed description
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
- Chronic Total Occlusion, Occlusion
- Being tested
- Chronic total occlusion percutaneous coronary intervention
- Keywords
- Physical Activity, CTO, PCI, Quality of Life, Percutaneous Coronary Intervention
- Medical subject headings
- Bites and Stings, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic total occlusion percutaneous coronary interventionProcedure or surgery
Chronic total occlusion percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for CTO PCI | Not described Receives: Procedure: Chronic total occlusion percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily steps compared with baseline
Significant change in daily steps at 3-month follow-up (as measured by smart watch)
Measured: 3 Months
Secondary outcomes (2)
Change in calorie expenditure
Change in calorie expenditure (as measured by smart watch) at 3-month follow-up
Measured: 3 Months
Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score follow-up compared with baseline
Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score at 3-month follow-up compared with baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2024
Why it stopped: Recruitment not possible in study location given study population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanouil Brilakis, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440084
- Sponsor's protocol ID
- 1913793
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Total Occlusion Percutaneous Coronary Intervention on Regular Physical Activity
- ClinicalTrials.gov ID
- NCT05440084
- Acronym / sponsor ID
- 1913793
- Conditions
- Chronic Total Occlusion, Occlusion
- Keywords
- Physical Activity, CTO, PCI, Quality of Life, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment not possible in study location given study population.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for CTO PCI | – | Procedure: Chronic total occlusion percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for CTO PCI at Minneapolis Heart Institute
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion)
- Plan for major surgical procedure (other than CTO PCI) which would limit exercise capability
- Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic total occlusion percutaneous coronary interventionChronic total occlusion percutaneous coronary intervention | Procedure or surgery | Patients referred for CTO PCI |
Primary outcome
Change in daily steps compared with baseline
Time frame: 3 Months
Significant change in daily steps at 3-month follow-up (as measured by smart watch)
2 secondary outcomes
Change in calorie expenditure
Time frame: 3 Months
Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score follow-up compared with baseline
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruitment not possible in study location given study population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil Brilakis, MD, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion and Occlusion, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment not possible in study location given study population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily steps compared with baseline (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.