CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification

NCT01061398 | Unknown DMC

• 1 other identifier: WU#08-12032
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with chest pain or shortness of breath who are referred for stress imaging tests (either stress echocardiography or stress nuclear testing), the investigators seek to compare impact of using cardiac CT scans of the heart arteries to the stress test that their doctors ordered.

Conditions

Coronary Artery Disease; Chest Pain; Coronary Atherosclerosis; Stress Testing

Keywords

cardiac ct; stress testing; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Rates of adverse cardiac events and resource utilization (rates of additional diagnostic tests that are performed for the initial complaint of angina/angina equivalent and clinical outpatient/inpatient/ED encounters for the initial cardiac complaint)

  24 months

Secondary Outcomes (8)

• Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization)

  24 months

• Total number and per-patient rates of subsequent cardiac diagnostic tests performed (stress tests, cardiac catheterizations, other tests) for the initial complaint of angina/angina equivalent

  24 months

• Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint

  24 months

• Avoidance of unnecessary cardiac catheterizations. An unnecessary cardiac catheterization is defined as a catheterization showing non-obstructive coronary disease and no cause for the symptoms.

  24 months

• Change in motivation for healthy behavioral change

  24 months

Study Arms (2)

Cardiac CT Arm

EXPERIMENTAL

Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan.

Procedure: Cardiac CT Angiography

No CT Arm

ACTIVE COMPARATOR

Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician.

Procedure: Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)

Interventions

Cardiac CT Angiography PROCEDURE

Patients randomized to CT Arm will undergo 64-slice cardiac CT angiography (single scan) in addition to the stress imaging test ordered by their physician

Cardiac CT Arm

Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram) PROCEDURE

Stress imaging test as ordered by the subjects provider without option for cardiac CT angiography (no CT arm)

No CT Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years of age at time of enrollment.
• Chest pain or anginal equivalent symptoms possibly suggestive of symptomatic coronary artery disease
• Low-intermediate risk (\<75% pretest probability) for symptomatic coronary artery disease on basis of age, sex, and quality of reported symptom as classified by the Diamond and Forrester scheme.
• Referred for a either a stress echocardiogram or a nuclear stress perfusion study.
• Ability to provide informed consent.

You may not qualify if:

• Presence of known pre-existing coronary artery disease (known prior myocardial infarction, ECG evidence of prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
• Previous outpatient or inpatient evaluation for coronary artery disease to include exercise treadmill testing, stress echocardiography or nuclear myocardial perfusion studies within the last 24 months.
• Presence of signs or symptoms that are clearly compatible with non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
• Renal insufficiency (creatinine \>1.5mg/dl) or renal failure requiring dialysis.
• Baseline heart rate \> 100bpm, atrial fibrillation or other markedly irregular rhythm (frequent ectopy, multifocal atrial tachycardia) on baseline ECG.
• Pregnancy or unknown pregnancy status.
• Known allergy to iodinated contrast.
• Inability to tolerate beta-blocking drugs, including patients with reactive airways disease requiring maintenance inhaled bronchodilators or steroids, complete heart block or second-degree atrioventricular block.
• Patients with hyperthyroidism including Grave's disease and toxic multinodular goiter
• Computed tomography imaging or iodinated contrast administration over 50 ml, within the past 48 hours.
• Inability to withhold ingestion of metformin or commonly used erectile dysfunction medications (Viagra, Cialis, Levitra) for 48 hours prior to and following MSCT scan.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; 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

• Todd C. Villines, M.D.

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: November 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)