Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain

Coronary Artery Disease Clinical Trial

— PROSPECT-CAD  

Official title:

A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01106612
• Other study ID #: MMC-07-07-197-a26
• Status: Terminated
• Phase: N/A
• First received: April 12, 2010
• Last updated: April 7, 2015
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• patient admitted for chest pain / pressure or other suggestive symptoms

• patient has known coronary artery disease (with or without prior revascularization)

• patient has clinical need for non-invasive cardiac evaluation

Exclusion Criteria:

• evidence of ongoing myocardial infarction or hemodynamic instability

• ischemia on EKG (greater than 1mm ST segment deviation)

• contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)

• heart rhythm precluding EKG gating

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Unstable Angina

Intervention

Procedure:
• Coronary CT angiography
EKG-gated, computed tomography angiography of the coronary arteries during heart rate control
• Myocardial perfusion imaging
Stress radionuclide myocardial perfusion imaging

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine of Yeshiva University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass		3 months	Yes
Secondary	Length of hospital stay (time to discharge)		1 month	No
Secondary	Number of participants that have a subsequent non-fatal myocardial infarction		1 year	Yes
Secondary	Number of participants that die due to any cause		1 year	Yes
Secondary	Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization		3 months	Yes