TerminatedNCT01836211TRUEUpdated Apr 19, 2013

High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain

An interventional study of Fast strategy and Standard of care strategy in Chest Pain and Acute Coronary Syndrome, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Terminated at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-04-19.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Diagnostic

Why this study was terminated

low recruitment

Phase: Not applicable
Study type: Interventional
Enrollment: 101
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).

Conditions studied

Chest Pain
Acute Coronary Syndrome

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Keywords

Chest pain
Acute coronary syndrome
Cardiac biomarkers
Computed coronary tomography angiography
Emergency department

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 101 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

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Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with chest pain consistent with possible acute coronary syndrome.
Age > 18 years.
Informed consent.

Exclusion criteria

Exclusion Criteria:

Previous history of coronary artery disease.
Electrocardiogram diagnostic or suggestive of myocardial ischemia.
Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
Chronic kidney disease (GFR \<30 mL/min/1,73 m2).
Iodine contrast allergy.
Incapability to perform treadmill stress test.
Barthel activity of daily living scale index \< 100.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 101 participants (actual)

Study arms

Experimental
Fast strategy
High sensitivity cardiac troponin T followed by computed coronary tomography angiography
Other: Fast strategy
Active comparator
Standard of care strategy
Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
Other: Standard of care strategy

Interventions

OtherFast strategy
High sensitivity troponin T followed by computed coronary tomography angiography
OtherStandard of care strategy
Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study

What researchers measure

Primary outcomes

All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Composite end-point.
Time frame: 1 month after index event

Secondary outcomes

All cause mortality
Time frame: 1 month
Myocardial infarction
Time frame: 1 month
Unstable angina
Time frame: 1 month
Heart Failure
Time frame: 1 month
Hospital admission
New cardiovascular hospital admission
Time frame: 1 month

Study locations

1 site

Hospital de la Santa Cruz y San Pablo
Barcelona, 08025, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01836211
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party: Sponsor
First posted: Apr 19, 2013
Start date: Sep 2011
Primary completion: Apr 2013 (estimated)
Completion: Jun 2013 (estimated)
Last update: Apr 19, 2013

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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