NCT02850432

Brief Summary

The aim of this study is to establish a clinically feasible simultaneous evaluation of heart and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI imaging markers in the evaluation of PAD and prediction of treatment outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

July 25, 2016

Last Update Submit

April 6, 2017

Conditions

Peripheral Arterial Disease

Keywords

Magnetic resonance imagingExtracellular volume matrix fractionPeripheral artery diseaseBlood-oxygen level dependentCardiac function

Outcome Measures

Primary Outcomes (1)

  • Post-treatment improvement of peripheral artery disease

    To determine the combined benefit of clinical and MRI imaging parameters (cardiac and lower extremities) in treatment response monitoring and treatment outcome prediction.

    2 years

Study Arms (2)

Invasive treatment

ACTIVE COMPARATOR

Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol

Procedure: Invasive treatment

Conservative treatment

ACTIVE COMPARATOR

rehabilitation with medical therapy

Other: Conservative treatment

Interventions

Invasive treatmentPROCEDURE

Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol

Also known as: Surgery or endovascular treatment
Invasive treatment
Conservative treatmentOTHER

rehabilitation with medical therapy

Also known as: rehabilitation with medical therapy
Conservative treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and provide signed informed consent
  • DM history of 10 years and above
  • Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable
  • Willing to receive standard therapy such as surgery or medication
  • Age between 18-80 years old

You may not qualify if:

  • Pregnant or breast-feeding women
  • Allergic MRI contrast medium
  • Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium).
  • Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball
  • Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility
  • Patients having dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

RECRUITING

Related Publications (1)

  • Lin YC, Fu TC, Lin G, Ng SH, Yeh CH, Ng SC, Chang TC, Juan YH. Using T1 mapping indices to evaluate muscle function and predict conservative treatment outcomes in diabetic patients with peripheral arterial disease. Eur Radiol. 2023 Jul;33(7):4927-4937. doi: 10.1007/s00330-023-09392-8. Epub 2023 Jan 18.

    PMID: 36651955DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Surgical Procedures, OperativeConservative TreatmentRehabilitation

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yu-Hsiang Juan, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Hsiang Juan, MD

CONTACT

+886-9-753-66388Jonat126@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 1, 2016

Study Start

May 1, 2016

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

TW(1)