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Outpatient vs Hospital Evaluation for Chest Pain (CARE-CP Trial)
N/A
Recruiting
Led By Simon Mahler, MD, MS
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No Patients with ≥ 70% Obstructive Coronary Disease
Age ≥21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
CARE-CP Trial Summary
This trial will study if an outpatient evaluation or hospitalization is best for patients with chest pain at risk for ACS. Patients will be randomized to one of the two in the Emergency Department.
Who is the study for?
This trial is for adults over 21 with chest pain or symptoms suggesting a moderate risk of acute coronary syndrome, but without severe heart conditions like prior heart attacks or major artery blockages. They must have normal troponin levels and no other serious health issues that require hospitalization.Check my eligibility
What is being tested?
The CARE-CP study is testing whether it's better to evaluate patients with acute chest pain through rapid outpatient care or traditional hospitalization. Participants are randomly assigned to one of these two approaches in the emergency department.See study design
What are the potential side effects?
Since this trial compares different evaluation methods rather than medications, side effects aren't the focus here. However, there may be risks associated with unnecessary hospital stays or delayed diagnosis depending on the evaluation method used.
CARE-CP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's arteries are not 70% or more blocked.
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I am 21 years old or older.
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I am experiencing chest pain or symptoms similar to a heart attack.
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My heart risk score is moderate, and my ECG doesn't show heart damage.
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I have never had coronary artery disease.
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I have never had a procedure to improve blood flow to my heart.
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I have never had a heart attack.
CARE-CP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital-free days (HFD) at 30-days post-randomization
Secondary outcome measures
Cardiovascular Hospital-free days (HFD) at 1 year post-randomization
Cardiovascular Hospital-free days (HFD) at 30-days post-randomization
Cardiovascular rehospitalizations at 1 year post-randomization
+12 moreCARE-CP Trial Design
2Treatment groups
Experimental Treatment
Group I: Outpatient EvaluationExperimental Treatment1 Intervention
Patients randomized to this arm are discharged and receive outpatient evaluation, or cardiovascular ambulatory rapid evaluation (CARE), focused on medical management for cardiovascular risk factors (e.g. hypertension) within 72 hours of Emergency Department discharge.
Group II: Hospitalization EvaluationExperimental Treatment1 Intervention
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,228 Total Patients Enrolled
9 Trials studying Chest Pain
16,908 Patients Enrolled for Chest Pain
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,846 Total Patients Enrolled
1 Trials studying Chest Pain
700 Patients Enrolled for Chest Pain
Simon Mahler, MD, MSPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
511 Total Patients Enrolled
1 Trials studying Chest Pain
511 Patients Enrolled for Chest Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a severe type of heart attack.You have significant changes in your ECG, like new T-wave inversions or ST changes of 1mm or more.Your troponin levels have changed by 5 or more pg/mL over time.I have other health conditions that needed hospital care.My heart's arteries are not 70% or more blocked.You are expected to live less than 1 year.My kidneys are failing, and I am on dialysis or have very low kidney function.I am 21 years old or older.I am experiencing chest pain or symptoms similar to a heart attack.My heart risk score is moderate, and my ECG doesn't show heart damage.My troponin levels are higher than normal for my gender.I have never had coronary artery disease.I have had a heart stress test or imaging within the last year.Your troponin levels are below a certain limit based on your gender.Your blood pressure, heart rate, or oxygen levels are not within the normal range.I have never had a procedure to improve blood flow to my heart.I have never had a heart attack.My heart scan in the last 2 years showed no blockages.I have had a chest injury.
Research Study Groups:
This trial has the following groups:- Group 1: Hospitalization Evaluation
- Group 2: Outpatient Evaluation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment presently open to participants?
"The clinical trial is not currently open for recruitment according to data on clinicaltrials.gov, despite having been initially posted on October 1st 2023 and last edited June 1st of the same year. Nevertheless, 32 other studies are presently admitting patients into their trials."
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