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

Occlusion Clinical Trial

Official title:

Impact of Chronic Total Occlusion Percutaneous Coronary Intervention on Regular Physical Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05440084
• Other study ID #: 1913793
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2022
• Source: Minneapolis Heart Institute Foundation
• Contact: Bavana Rangan, BDS, MPH
• Phone: 817-821-9945
• Email: bavana.rangan[@]allina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Occlusion

Intervention

Procedure:
• Chronic total occlusion percutaneous coronary intervention
Chronic total occlusion percutaneous coronary intervention

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Change in calorie expenditure	Change in calorie expenditure (as measured by smart watch) at 3-month follow-up	3 Months
Secondary	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