Acute Coronary Syndrome Clinical Trial
Official title:
Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Verified date | December 2022 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage. This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 16, 2021 |
Est. primary completion date | February 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins Exclusion Criteria: - age less than 18 - cognitive impairment (per MMSE) - geographic unavailability for followup - unwillingness to participate - illiteracy - Hx cardiac transplant - untreated hypothyroidism - hepatic dysfunction - prior adverse reaction to citalopram - history of Bipolar Disorder - untreated Sleep Apnea - chronic steroid therapy - active substance abuse (e.g., within past year) - near term mortal illness - current mental health treatment - signitificant suicide risk |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of ACS Symptoms | Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations | 6 months | |
Primary | Treatment usage | ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays | 6 months | |
Secondary | Emotional Distress | Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC | 6 months |
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