Status:
COMPLETED
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Diseases
Depression
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatm...
Detailed Description
Objectives: To examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) p...
Eligibility Criteria
Inclusion
- Hospitalization with a verified diagnosis of unstable angina (UA) or acute myocardial infarction (AMI). UA is defined as new-onset angina within 2 months, exacerbation of previous angina with pain at rest or with minimal exercise, prolonged chest pain (lasting \> 20 minutes), or angina within 2 weeks following discharge for myocardial infarction in patients with documented coronary artery disease (defined as ischemic ECG ST-T segment changes, previously documented MI, positive nuclear treadmill test result, or coronary angiographic evidence of blockage of 50% stenosis in \>1 major coronary artery). AMI is defined as at least 2 of the following: ischemic chest pain lasting \>20 minutes, acute rise in serum troponin-I \>1.0 ng/L, and new pathologic ST segments in \>2 contiguous ECG leads.
- Score on the Beck Depression Inventory (BDI) \> 10 within 7 days of index ACS event and 3-months later.
Exclusion
- active suicidal or homicidal ideation, as these patients require immediate referral for assessment and treatment (see below for procedures for these patients);
- current alcohol or other substance abuse disorders (as depressive symptoms may be a result of these disorders),
- any current psychotic disorder,
- history of psychotic disorder, bipolar disorder, or serious personality disorders,
- diagnosis of a terminal non-cardiac illness,
- ACS diagnosis secondary to diagnosis of a severe medical disease,
- inability to communicate in English,
- levels of cognitive impairment indicative of dementia,
- unavailability for the period of the study,
- overt hypothyroid, and
- currently taking triptans.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00158054
Start Date
January 1 2005
End Date
April 1 2015
Last Update
August 23 2017
Active Locations (3)
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1
Yale University
New Haven, Connecticut, United States, 06520
2
Mount Sinai School of Medicine
New York, New York, United States, 10029
3
Columbia University
New York, New York, United States, 10032