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Procedure

PET/CT vs. Cardiac CT for Coronary Artery Disease (PET; CT Trial)

N/A
Recruiting
Led By Armin Zadeh, MD PhD MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Referred for coronary CT angiography because of suspected coronary heart disease (CHD) with stable symptoms
Be older than 18 years old
Must not have
History of coronary heart disease, defined by prior myocardial infarction or prior coronary artery revascularization
Atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess coronary artery plaque in 33 patients with suspected CAD using 3 different imaging tests. Early detection facilitates prevention. #medicine #cardiology

Who is the study for?
This trial is for men and women over 18 who have stable symptoms suggesting coronary artery disease (CAD) and are referred for a coronary CT angiography. It's not suitable for pregnant individuals, those with severe obesity (BMI >40), a history of heart disease, atrial fibrillation, or any condition that could affect their participation as per the investigator.
What is being tested?
The study compares two imaging methods to detect coronary atherosclerotic disease: PET/CT versus conventional and ultra-high-resolution cardiac CT. The goal is to determine which method better identifies CAD in patients showing symptoms suggestive of this condition.
What are the potential side effects?
While the document does not specify side effects, generally PET/CT scans may cause discomfort from lying still during the test or reactions to contrast agents if used—like mild itching or rash. Cardiac CT scans carry minimal risks such as exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am referred for a heart scan due to stable heart disease symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a heart attack or surgery to improve blood flow to my heart.
Select...
I have atrial fibrillation.
Select...
My BMI is over 40, indicating morbid obesity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlation of atheroma volume [mm3]
Diagnostic accuracy of detecting coronary atherosclerosis

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02338999
9%
White blood cell count decreased
9%
Upper respiratory tract infection
6%
Fatigue
6%
Alanine aminotransferase increased
5%
Nausea
5%
Pain in extremity
5%
Dizziness
4%
Viral upper respiratory tract infection
4%
Anaemia
4%
Cardiac murmur
4%
Weight increased
4%
Dysuria
4%
Abdominal distension
3%
Rhinitis allergic
3%
Gastritis
3%
Paraesthesia
3%
Headache
3%
Somnolence
3%
Dyspepsia
3%
Aspartate aminotransferase increased
3%
Micturition disorder
3%
Dyspnoea
3%
Wheezing
3%
Platelet count decreased
1%
Pharyngitis
1%
Urinary tract infection
1%
Numbness
1%
Computerised tomogram coronary artery abnormal
1%
Arthropod bite
1%
Laryngeal inflammation
1%
Frequent bowel movements
1%
Lymphadenopathy
1%
Episcleritis
1%
Fall
1%
Leukopenia
1%
Gastrooesophageal reflux disease
1%
Abdominal pain
1%
Gastritis viral
1%
Vaginal infection
1%
Oedema peripheral
1%
Blood bicarbonate decreased
1%
Myalgia
1%
Fluid retention
1%
Decreased appetite
1%
Weight decreased
1%
Memory impairment
1%
Computerised tomogram abnormal
1%
Anorexia nervosa
1%
Hypertriglyceridaemia
1%
Vomiting
1%
Biopsy lymph gland
1%
Muscle spasms
1%
Disturbance in attention
1%
Blood creatinine increased
1%
Insomnia
1%
Panic attack
1%
Hot flush
1%
Lacrimation increased
1%
Constipation
1%
Diarrhoea
1%
Dysphagia
1%
Influenza like illness
1%
Localised oedema
1%
Herpes zoster
1%
Sinusitis
1%
Increased appetite
1%
Chills
1%
Galactorrhoea
1%
Cough
1%
Pain of Skin
1%
Pruritus
1%
Thyroid mass
1%
Helicobacter test positive
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pioglitazone
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Main groupExperimental Treatment1 Intervention
All patients undergo both, experimental and standard, tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT
2022
Completed Phase 3
~1300

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,753 Total Patients Enrolled
27 Trials studying Coronary Artery Disease
56,505 Patients Enrolled for Coronary Artery Disease
Armin Zadeh, MD PhD MPHPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

PET/CT (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05994014 — N/A
Coronary Artery Disease Research Study Groups: Main group
Coronary Artery Disease Clinical Trial 2023: PET/CT Highlights & Side Effects. Trial Name: NCT05994014 — N/A
PET/CT (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994014 — N/A
~16 spots leftby Jun 2026
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