Screening and intervention for subclinical coronary artery disease in patients with type 2 diabetes: THE STENO INTEN-CT STUDY

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500143-21-01

Acronym

INTEN-CT

Enrollment

7300

Registered

2022-07-08

Start date

2023-01-12

Completion date

Unknown

Last updated

2024-09-20

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

Conditions

Type 2 diabetes

Brief summary

Rates of a composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).

Detailed description

Separate cardiovascular endpoints, all-cause mortality, and renal failure., Patient reported outcomes (EQ-5D questionnaire), Quality adjusted life years (QALY) using data from the EQ-5D questionnaire and Danish preference weights of the normal population. Register-based rates of procedural codes encompassing tests for atherosclerosis/ischemia of the heart, brain or peripheral circulation and register-based rates of prescription of drugs used in CVD prophylaxis (glucose-lowering drugs, antihypertensive drugs, lipid-lowering drugs and antithrombotic drugs).

Interventions

DRUGOzempic 1 mg solution for injection in pre-filled pen

DRUGOzempic 0.25 mg solution for injection in pre-filled pen

DRUGNitrolingual Pumpspray 400 micrograms per metered dose

DRUGsublingual spray.

DRUGIvabradin Medical Valley 5 mg filmdragerade tabletter

DRUGForxiga 10 mg film-coated tablets

DRUGIomeron 350 mg I/ml injektionsvätska

DRUGlösning

DRUGSeloken 1 mg/ml injektionsvätska

DRUGAtenolol Orifarm 50 mg tabletter

DRUGOzempic 0.5 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rates of a composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).	—

Secondary

Measure	Time frame
Separate cardiovascular endpoints, all-cause mortality, and renal failure., Patient reported outcomes (EQ-5D questionnaire), Quality adjusted life years (QALY) using data from the EQ-5D questionnaire and Danish preference weights of the normal population. Register-based rates of procedural codes encompassing tests for atherosclerosis/ischemia of the heart, brain or peripheral circulation and register-based rates of prescription of drugs used in CVD prophylaxis (glucose-lowering drugs, antihypertensive drugs, lipid-lowering drugs and antithrombotic drugs).	—

Measure

Time frame

—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026