NCT06237673

Brief Summary

CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain. Overall goal: The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

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

December 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

December 20, 2023

Last Update Submit

March 18, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Comparison of coronary plaque burden (non-calcified plaque volume (NCPV) measured by CT at 10-years between the initial randomization CT and ICA groups

    at 10 years

  • Comparison of coronary plaque burden total plaque volume (TPV)) measured by CT at 10-years between CT and ICA groups

    at 10 years

Secondary Outcomes (2)

  • Intraindividual progression of coronary artery disease (defined as change in coronary plaque burden from the first CT until the CT examination after 10 years) in the CT group.

    at 10 years

  • Comparison of the difference in chronic kidney injury, (eGFR and as increase in creatinine by 25% or 0.5 mg/dl) in both groups at 10-year follow-up between CT and ICA groups.

    at 10 years

Other Outcomes (22)

  • To compare minor cardiovascular events at final follow-up (after approximately 10 years).

    at 10 years

  • To compare the cost-effectiveness in both groups. (after 10 years).

    at 10 years

  • Comparison of two types of structured reports one medical and one using easy language (according to the german clinical practice guidelines) using patient acceptance questionnaire.

    at 10 years

  • +19 more other outcomes

Study Arms (2)

CT

EXPERIMENTAL

CT-directed clinical management strategy

Diagnostic Test: CT

Invasive coronary angiography (ICA)

ACTIVE COMPARATOR

Standard clinical management directed by conventional invasive coronary angiography (ICA).

Diagnostic Test: invasive coronary angiography (ICA)

Interventions

CTDIAGNOSTIC_TEST

CT-directed clinical management strategy

CT
invasive coronary angiography (ICA)DIAGNOSTIC_TEST

Standard clinical management directed by conventional invasive coronary angiography (ICA).

Invasive coronary angiography (ICA)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected CAD
  • Patients with atypical angina
  • Patients who have previously participated in the CAD-Man study and have not died at a median follow-up of 3.3 years.

You may not qualify if:

  • Pregnancy
  • Any health condition that would cause concern that participation would not be in the best interest of health (eg, extensive comorbidities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (6)

  • Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.

    PMID: 27777234BACKGROUND

  • Schonenberger E, Martus P, Bosserdt M, Zimmermann E, Tauber R, Laule M, Dewey M. Kidney Injury after Intravenous versus Intra-arterial Contrast Agent in Patients Suspected of Having Coronary Artery Disease: A Randomized Trial. Radiology. 2019 Sep;292(3):664-672. doi: 10.1148/radiol.2019182220. Epub 2019 Jul 2.

    PMID: 31264950BACKGROUND

  • Bosserdt M, Martus P, Tauber R, Dreger H, Dewey M, Schonenberger E; CAD-Man Study Group Investigators. Serum creatinine baseline fluctuation and acute kidney injury after intravenous or intra-arterial contrast agent administration-an intraindividual comparison as part of a randomized controlled trial. Nephrol Dial Transplant. 2022 May 25;37(6):1191-1194. doi: 10.1093/ndt/gfac013. No abstract available.

    PMID: 35090035BACKGROUND

  • Bosserdt M, Feger S, Rief M, Preuss D, Ibes P, Martus P, Kofoed KF, Laule M, Perez I, Dewey M. Performing Computed Tomography Instead of Invasive Coronary Angiography: Sex Effects in Patients With Suspected CAD. JACC Cardiovasc Imaging. 2020 Mar;13(3):888-889. doi: 10.1016/j.jcmg.2019.10.014. Epub 2019 Dec 18. No abstract available.

    PMID: 31864987BACKGROUND

  • Laskowski D, Feger S, Bosserdt M, Zimmermann E, Mohamed M, Kendziora B, Rief M, Dreger H, Estrella M, Dewey M. Detection of relevant extracardiac findings on coronary computed tomography angiography vs. invasive coronary angiography. Eur Radiol. 2022 Jan;32(1):122-131. doi: 10.1007/s00330-021-07967-x. Epub 2021 Jun 15.

    PMID: 34129067BACKGROUND

  • Feger S, Elzenbeck L, Rieckmann N, Marek A, Dreger H, Beling M, Zimmermann E, Rief M, Chow BJW, Maurovich-Horvath P, Laule M, Tauber R, Dewey M. Effect of Computed Tomography Versus Invasive Coronary Angiography on Statin Adherence: A Randomized Controlled Trial. JACC Cardiovasc Imaging. 2021 Jul;14(7):1480-1483. doi: 10.1016/j.jcmg.2021.01.032. Epub 2021 May 19. No abstract available.

    PMID: 34023253BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr. h.c. Marc Dewey

Study Record Dates

First Submitted

December 20, 2023

First Posted

February 1, 2024

Study Start

December 1, 2023

Primary Completion

January 11, 2025

Study Completion

January 29, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

We will share individual patient data from CAD-Man extend study via the GUIDE-IT platform.

Shared Documents
STUDY PROTOCOL
Time Frame
12 months after publication. End 3 years after publication
Access Criteria
Researchers who provide a methodologically sound proposal approved by the Dissemination Committee of CAD-Man and GUIDE-IT. The study proposal must include: The proposed study's overview, rationale, aims and analysis methods, plans for dissemination of results and names of those wishing to access data, and how is the data going to be stored and for how long.
More information

Locations

DE(1)