Change in Exercise Capacity as Measured by Peak Oxygen Uptake After CTO PCI

NCT02499666 | Terminated

• 1 other identifier: 9608
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to objectively assess the change (improvement) in exercise capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic total occlusion (CTO)

Conditions

Coronary Artery Disease; Angina Pectoris

Keywords

Exercise Capacity; Chronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

• Change in Exercise Capacity

  Evaluate change in exercise capacity as determined by peak VO2 by comparing pre and post percutaneous intervention cardiopulmonary exercise test results

  Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention

Secondary Outcomes (1)

• Predictors of Change in Exercise Capacity

  Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention

Study Arms (2)

Asymptomatic

Patients with known chronic total occlusion who are undergoing percutaneous coronary intervention wtih balloon angioplasty and coronary stent placement who are currently asymptomatic (without any chest pain or anginal equivalent) but have decreased exercise capacity or are easily fatigued. Patients will also be on dual antiplatelet therapy with aspirin and a second agent such as clopidogrel.

Procedure: Percutaneous Coronary Intervention; Device: Coronary stent; Drug: Clopidogrel

Symptomatic

Patients with known chronic total occlusion who are undergoing percutaneous coronary intervention with balloon angioplasty and coronary stent placement who are currently symptomatic with chest pain or anginal equivalent.. Patients will also be on dual antiplatelet therapy with aspirin and a second agent such as clopidogrel.

Procedure: Percutaneous Coronary Intervention; Device: Coronary stent; Drug: Clopidogrel

Interventions

Percutaneous Coronary Intervention PROCEDURE

As clinically indicated, patients will have a percutaneous balloon angioplasty and stent deployment of a chronic total occlusion (i.e., an artery that has a 100% blockage for several months).

Asymptomatic; Symptomatic

Coronary stent DEVICE

As clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty

Asymptomatic; Symptomatic

Clopidogrel DRUG

As clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel.

Also known as: Plavix

Asymptomatic; Symptomatic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who present for evalaution of CTO-PCI (male and female, age \>18 years old) will be asked to participate in the study. Patients unable to exercise for any reason will be excluded.

You may qualify if:

• Patients who present for percutaneous intervention of chronic total occlusion who are able and willing to perform treadmill cardiopulmonary stress testing before and after the intervention

You may not qualify if:

• Patients who present for percutaneous intervention of chronic total occlusion who are unable or unwilling to perform treadmill cardiopulmonary stress testing before and after the intervention

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Percutaneous Coronary Intervention; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Khaldoon Alaswad, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Laboratory

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 16, 2015
• Study Start: June 29, 2015
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

US (1)