NCT00189111

Brief Summary

The purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 15, 2018

Status Verified

November 1, 2016

First QC Date

September 12, 2005

Last Update Submit

February 14, 2018

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial diseasecomputed tomographycardiac asymptomaticdobutamine magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • cardiovascular mortality

  • cardiovascular morbidity

Secondary Outcomes (9)

  • Fatal and non-fatal myocardial infarction

  • Fatal and non-fatal stroke

  • Vascular interventions

  • Amputation

  • Aortic rupture

  • +4 more secondary outcomes

Interventions

Cardiac Imaging + TreatmentPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with peripheral arterial disease, diagnosed by the vascular surgeon
  • Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician
  • Patients must be aged 50 years or over

You may not qualify if:

  • History of symptomatic cardiac disease
  • Cardiac rhythm other than sinus
  • Unable to sustain a breath-hold for 25 seconds
  • Asthma (contraindication beta-blockers)
  • Contra-indications to MRI examination.
  • Contra-indications to iodine contrast.
  • Severe arterial hypertension (\>220/120 mmHg)
  • Significant aortic stenosis
  • Unable to remain in supine position for at least 60 minutes
  • Morbidly obese (BMI \> 40)
  • Renal insufficiency (creatinine \>140mmol/l)
  • Severe physical deterioration due to concomitant illness
  • Language barrier
  • Acute coronary syndrome
  • Contra-indications to dobutamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bronovo Hospital

The Hague, South Holland, 2597 AX, Netherlands

Location

Meander Medical Center

Amersfoort, Utrecht, 3800 BM, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

  • de Vos AM, Rutten A, van de Zaag-Loonen HJ, Bots ML, Dikkers R, Buiskool RA, Mali WP, Lubbers DD, Mosterd A, Prokop M, Rensing BJ, Cramer MJ, van Es HW, Moll FL, van de Pavoordt ED, Doevendans PA, Velthuis BK, Mackaay AJ, Zijlstra F, Oudkerk M. Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial. Trials. 2008 Aug 1;9:49. doi: 10.1186/1745-6215-9-49.

    PMID: 18673542DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • W. Mali, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • M. Oudkerk, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • M.L. Bots, PhD

    Julius Center, University Medical Center Utrecht

    PRINCIPAL INVESTIGATOR

  • F. Zijlstra, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical research coordinator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Study Completion

April 1, 2012

Last Updated

February 15, 2018

Record last verified: 2016-11

Locations

NL(5)