NCT05609214

Brief Summary

The goal of this observational study is to evaluate the complimentary information of anatomy, perfusion and viability of PET and MR. The main question\[s\] it aims to answer are:

  • to compare perfusion and anatomy measurements and perfusion related signals from PET and MR imaging and estimate its prognostic values.
  • to evaluate potential optimization of routine scanning procedure with regards to completeness and potential added value of quantitative measurements.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress86%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

November 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

November 1, 2022

Last Update Submit

November 30, 2023

Conditions

Keywords

Myocardial Perfusion

Outcome Measures

Primary Outcomes (1)

  • Complimentary information on perfusion and metabolism

    To evaluate complimentary information on perfusion and metabolism assessed by PET and MR imaging to better identify individuals with known or suspected coronary artery disease

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with known or suspected coronary artery disease who are referred for noninvasive cardiac evaluation, clinically indicated cardiac anatomy, viability and/or perfusion evaluation by MRI or PET scan

You may qualify if:

  • Male and Female participants over the age of 18 years
  • Written informed consent by the participant after information about the research project
  • Symptoms consistent with possible coronary artery disease
  • Clinical referral for a vasodilator stress CMR and/or PET examination

You may not qualify if:

  • Patients with high degree heart block
  • Contraindications to gadolinium-enhanced CMR examination
  • Severe claustrophobia
  • Specific implantable devices which are contraindicated for CMR
  • Current pregnancy
  • Advanced renal disease (GFR\<30)
  • Uncontrolled obstructive pulmonary disease or asthma
  • Atrial fibrillation at the time of study enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Aju P Pazhenkottil

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aju P Pazhenkottil, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 8, 2022

Study Start

November 21, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations