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Coronary Stent

Change in Exercise Capacity as Measured by Peak Oxygen Uptake After CTO PCI (EXERTION Trial)

N/A

Waitlist Available

Led By Khaldoon Alaswad, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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)

Eligible Conditions

Angina
Coronary Artery Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Exercise Capacity

Secondary study objectives

Predictors of Change in Exercise Capacity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SymptomaticExperimental Treatment3 Interventions

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.

Group II: AsymptomaticExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coronary stent

2014

Completed Phase 2

~670

Clopidogrel

2010

Completed Phase 4

~9160