NCT03520400: PAUSE

PCI Alternative Using Sustained Exercise

Completed NA Results posted Last updated 2 February 2024

What this trial tests

NA trial testing Exercise Therapy in Cardiovascular Disease in 51 participants. Completed in 30 September 2019.

Timeline

1 October 2012

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	51
Start date	1 October 2012
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Exercise Therapy

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 45 to 75, any sex, with Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Myocardial Perfusion Reserve Primary · baseline and 1 year

Measurement of myocardial blood flow has only been analyzed at baseline at this time. Intravenous 13NH3 will be used as the flow tracer and serial imaging with PET will be performed. Measurements will be performed at baseline, and after pharmacologic stress with dipyridamole. Myocardial blood flow at rest and following dipyridamole infusion will be expressed as ml flow/100 g/min. The myocardial perfusion reserve will be calculated as the ratio of the myocardial blood flow during stress (e.g. after dipyridamole) and the myocardial blood flow at rest. Commercially available software (Emory tool

Baseline

Group	Value	95% CI
Exercise Intervention Group	2.76	± 0.61
PCI Group (Usual Care)	2.47	± 0.48

1-year

Group	Value	95% CI
Exercise Intervention Group	2.82	± 0.56
PCI Group (Usual Care)	2.52	± 0.43

Peak VO2 Secondary · baseline and after 1 year

Peak VO2 will be determined at baseline and 1 year on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.

Baseline

Group	Value	95% CI
Exercise Intervention Group	20.21	± 3.76
PCI Group (Usual Care)	19.85	± 6.5

1 Year

Group	Value	95% CI
Exercise Intervention Group	22.4	± 4.10
PCI Group (Usual Care)	18.91	± 5.92

Sponsor's own description

Cardiovascular disease remains the leading cause of morbidity and mortality in the U.S. and is a major cause of disability in Veterans. Most of these deaths are due to coronary artery disease (CAD). The most common treatment for CAD is revascularization, an invasive procedure which usually involves placing a stent inside an artery that is diseased. However, exercise training is often overlooked because clinicians tend to focus on repairing the coronary circulation and the potential need for revascularization. Studies have shown that exercise training can be effective for patients with CAD and that it saves costs. In this study, invasive revascularization will be compared to a structured program of exercise training over one year. Comparisons will be made between groups for symptoms, coronary artery size and function using PET/CTA, and health care cost utilization.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.