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

NCT01106612 | Terminated DMC

• 1 other identifier: MMC-07-07-197-a26
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Angina Pectoris; Unstable Angina; Acute Coronary Syndrome

Keywords

randomized controlled trial; controlled clinical trial; comparative effectiveness research; chest pain; angina pectoris; non-invasive cardiac imaging; nuclear stress testing; coronary CT angiography; coronary catheterization; coronary revascularization

Outcome Measures

Primary Outcomes (1)

• Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass

  3 months

Secondary Outcomes (4)

• Length of hospital stay (time to discharge)

  1 month

• Number of participants that have a subsequent non-fatal myocardial infarction

  1 year

• Number of participants that die due to any cause

  1 year

• Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization

  3 months

Study Arms (2)

Initial coronary CT angiography

EXPERIMENTAL

EKG-gated, computed tomography angiography of the coronary arteries during heart rate control

Procedure: Coronary CT angiography

Initial nuclear stress test

ACTIVE COMPARATOR

Stress radionuclide myocardial perfusion imaging

Procedure: Myocardial perfusion imaging

Interventions

Coronary CT angiography PROCEDURE

EKG-gated, computed tomography angiography of the coronary arteries during heart rate control

Also known as: Coronary CTA, Coronary CT, CTA of the coronary arteries, CT of the coronary arteries, CTA, CCTA, Cardiac CTA, Cardiac CT, CT Angiography of the coronary arteries, Computed tomography angiography of the coronary arteries

Initial coronary CT angiography

Myocardial perfusion imaging PROCEDURE

Stress radionuclide myocardial perfusion imaging

Also known as: MPI, MPS, stress MPI, stress MPS, radionuclide MPI, stress nuclear, nuclear stress, nuclear stress test, nuclear stress testing, nuclear cardiology, nuclear perfusion imaging, nuclear myocardial perfusion imaging, myocardial perfusion

Initial nuclear stress test

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Angina, Unstable; Acute Coronary Syndrome; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda B Haramati, MD, MS

  Montefiore Medical Center/Albert Einstein College of Medicine

  STUDY DIRECTOR

• Jeffrey M Levsky, MD, PhD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 20, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

US (1)