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OpenTrials
Completed

NCT Number: NCT00248976

Improving Health Behavior and Outcomes After Angioplasty

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.

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Key information

Conditions

Angioplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian College-Weill Medical Center

New York, 10021, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Net-present value of individual health behaviors in years

Behavioral

Primary outcomes

  1. Mortality

  2. Myocardial Infarction

  3. Angina

  4. Severe ischemia on non-invasive testing

  5. Stroke

Secondary outcomes

  1. 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.

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

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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Nov 4, 2005
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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