Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome

NCT02772991 | Unknown

• 1 other identifier: PSInCor-TropoUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, a large number of studies have been conducted on how to improve the treatment of patients in the Emergency Room (ER) complaining of chest pains. Great advances have been achieved recently regarding diagnostic methods aided by coronary CT angiopraphy (CCTA) and sensitive troponins. However, various questions about these methods still remain obscure and there is no effective comparison between them in patients with intermediate risk. The aim of the study is to evaluate the sensitivity and specificity of sensitivity troponins in the detection of coronary artery disease in patients with chest pain and the intermediate probability of ACS compared with CCTA.

Conditions

Chest Pain; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events according to phone contact after 30 days

  Patients whose CCTAs show lesions with stenosis of less than 50%, compare combined outcomes (death, AMI, rehospitalization, and stroke)with the increase/decrease of troponin in the second measurement in 30 days according to phone contact.

  30 days

• Compare the sensitivity, specificity, and negative and positive predictive values between the high sensitivity troponin and the CCTA in the detection of an ACS.

  ROC curve / ANOVA

  30 days

Secondary Outcomes (1)

• Stablish the cut off for troponin levels

  3 hours

Study Arms (1)

Cases

EXPERIMENTAL

All patients will be submmited to troponin measurements and CCTA. If CCTA shows coronary stenosis ≥ 50%, patient will initiate the ACS treatment and be hospitalized to have coronary cineangiography. If CCTA shows lesions \< 50%, the patient will be discharged and monitored for 30 days. A second sampling of the troponin will be obtained from all patients three hours after the first collection in order to evaluate for an increase/decrease of troponin.

Other: troponin measurement

Interventions

troponin measurement OTHER

Cardiac catheterization (for patients with \>50% lesions) or discharge or in patients with intermediate risk.

Also known as: coronary CT angiopraphy

Cases

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chest pain for at least two hours before arriving at the emergency unit
• non-diagnostic electrocardiogram (absence of new or probable deviation of ST of at least 0.5 mV and/or T wave inversion of at least 0.2 mV)
• TIMI risk of 3 or 4
• first measurement of troponin I less than or equal to ≤ 0.03 ng/ml
• informed consent form signed.

You may not qualify if:

• pregnancy
• hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
• serum creatinine higher than 1.5 mg/dL
• intolerance to ß-blockers
• allergy to iodinated contrast
• asthma
• thoracic trauma within the last 30 days
• body mass index greater than 40 kg/ m2
• previous surgical myocardial revascularization
• other identified causes of troponin increase

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 16, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)