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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Total Occlusion; Occlusion
• Intervention / Treatment: Procedure: Chronic total occlusion percutaneous coronary intervention

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for CTO PCI at Minneapolis Heart Institute

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients referred for CTO PCI	Procedure: Chronic total occlusion percutaneous coronary intervention; Chronic total occlusion percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily steps compared with baseline	Significant change in daily steps at 3-month follow-up (as measured by smart watch)	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in calorie expenditure	Change in calorie expenditure (as measured by smart watch) at 3-month follow-up	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	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-8 (PHQ-8) depression score	Change in Patient Health Questionnaire-8 (PHQ-8) depression score at 3-month follow-up compared with baseline	3 Months

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Investigators: Principal Investigator: Emmanouil Brilakis, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; PCI; Quality of Life; Percutaneous Coronary Intervention; CTO
• Other Study ID Numbers: 1913793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No