Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)

Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey) - Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003567

Enrollment

Registered

2010-05-05

Start date

2009-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Lipid-lowering therapy with strong-statin(pitavastatin, atorvastatin, or rosuvastatin) for a period of 12 months to achieve LDL-C&lt

80mg/dL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with coronary artery disease who have coronary plaque detected by MDCT. 2. Patients aged 20 and over. 3. Patients giving written consent on their own volition for participation in this clinical trial after being provided with sufficient explanation about the study.

Exclusion criteria

Exclusion criteria: 1. Patients scheduled to undergo PCI for evaluation of plaque during the treatment period. 2. Patients who had received PCI on the index lesion in the past where further evaluation of coronary plaque is planned. 3. Patients scheduled to undergo CABG during the treatment period. 4. Patients being treated with lipid-lowering agents(statins, fibrates, probucol, niacin, anion exchange resin, EPA, dextran sulfate sodium, and ezetimibe). 5. Patients who have allergy to pitavastatin, atorvastatin , or rosuvastatin. 6. Patients on cyclosporine therapy, and patients with liver dysfunction (AST or ALT values of >=100IU) or the following diseases considered to be associated with biliary obstruction and/or impaired hepatic function: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus. 7. Pregnant or possibly pregnant women, lactating women 8. Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or dialysis patients 9. Patients who are judged by the investigator to be not eligible for enrollment in the study

Design outcomes

Primary

Measure	Time frame
Change of coronary plaque signal intensity detected by MRI.	—

Secondary

Measure	Time frame
1. Correlation between baseline characteristics and coronary plaque signal intensity detected by MRI or MDCT. 2. Change from baseline to follow-up plaque density and area of plaque detected by MDCT. 3. Correlation between change in plaque signal intensity detected by MRI and change in plaque density or plaque volume detected by MDCT. 4. Correlation between change in plaque signal intensity detected by MRI and change in blood biomarkers.	—

Measure

Time frame

1. Correlation between baseline characteristics and coronary plaque signal intensity detected by MRI or MDCT. 2. Change from baseline to follow-up plaque density and area of plaque detected by MDCT. 3. Correlation between change in plaque signal intensity detected by MRI and change in plaque density or plaque volume detected by MDCT. 4. Correlation between change in plaque signal intensity detected by MRI and change in blood biomarkers.

—

Countries

Japan

Contacts

Public ContactTeruo Noguchi

National Cerebral and Cardiovascular Center Division of Cardiology, Department of Medicine

tnoguchi@hsp.ncvc.go.jp06-6833-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026