Clinical trial NCT05440084: Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity
Official title: Impact of Chronic Total Occlusion Percutaneous Coronary Intervention on Regular Physical Activity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Total Occlusion
Occlusion
Keywords: Physical Activity
CTO
PCI
Quality of Life
Percutaneous Coronary Intervention
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for CTO PCI at Minneapolis Heart Institute

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in daily steps compared with baseline
timeFrame: 3 Months
Secondary outcomes:
measure: Change in calorie expenditure
timeFrame: 3 Months
measure: Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score follow-up compared with baseline
timeFrame: 3 months
Other outcomes:
measure: Change in Patient Health Questionnaire-8 (PHQ-8) depression score
timeFrame: 3 Months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
affiliation: Principal Investigator
name: Emmanouil Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: