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

NCT05440084 | Terminated

• 1 other identifier: 1913793
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion; Occlusion

Keywords

Physical Activity; CTO; PCI; Quality of Life; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in calorie expenditure

  3 Months

• Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score follow-up compared with baseline

  3 months

Other Outcomes (1)

• Change in Patient Health Questionnaire-8 (PHQ-8) depression score

  3 Months

Study Arms (1)

Patients referred for CTO PCI

Procedure: Chronic total occlusion percutaneous coronary intervention

Interventions

Chronic total occlusion percutaneous coronary intervention PROCEDURE

Chronic total occlusion percutaneous coronary intervention

Patients referred for CTO PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for CTO PCI at Minneapolis Heart Institute

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Bites and Stings; Motor Activity

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Behavior

Study Officials

• Emmanouil Brilakis, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)