Improving Health Behavior and Outcomes After Angioplasty

Angioplasty Clinical Trial

Official title:

Improving Health Behavior and Outcomes After Angioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248976
• Other study ID #: 0698-267
• Status: Completed
• Phase: N/A
• Start date: April 1999
• Est. completion date: March 29, 2004

Study information

• Verified date: October 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this randomized trials is to evaluate, among coronary artery disease patients who have just had either angioplasty or stents, whether a novel intervention based on feedback of individualized risk profiles framed as the opportunity to reduce one's biological age is more effective after two years in reducing mortality and major cardiovascular morbidity (specifically, myocardial infarction, stroke, class II-IV angina, and severe ischemia) than the standard risk reduction approach, which is framed as one's opportunity to reduce future risk. The novel strategy is based on the theory of net-present value and is tested in coronary artery disease patients who have a high risk of adverse outcomes by two years.

Description:

1. To determine whether patients who receive the net-present value intervention have more improvements in their risk factor profile than those in the control group at two years.

2. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.

3. To determine whether the net-present value intervention will improve overall functional status and prevent further disability.

The long-term objective of this study is to determine whether a net-present value approach for motivation behavior change is effective in reducing risk factors, improving treatment outcomes, and enhancing quality of life among a high-risk group of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 29, 2004
• Est. primary completion date: March 29, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment. Patients must be able to provide informed consent within the one week after the procedures.

Exclusion criteria:

• Patients must be verbally fluent in English. To ascertain this, we ask the patient to rate their fluency on a scale of 1-10 (with 10 as best), and if the score is 7 or more, they are approached for consent. The patient must be able to provide their own consent without translation.

• Enrollment in other trials designed to modify post-procedure behaviors.

• Patients who refuse to participate will be excluded.

• If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.

Related Conditions & MeSH terms

• Angioplasty

Intervention

Behavioral:
• Net-present value of individual health behaviors in years

Locations

Country	Name	City	State
United States	New York Presbyterian College-Weill Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Myocardial Infarction
Primary	Angina
Primary	Severe ischemia on non-invasive testing
Primary	Stroke
Secondary	a. To determine whether patients who receive the net-present value intervention have more improvements in their risk factor profile than those in the control group at two years.
Secondary	b. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.
Secondary	c. To determine whether the net-present value intervention will improve overall functional status and prevent further disability.